Moxidectin

Simparica TRIO® is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Simparica TRIO® kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica TR O® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Simparica TRIO®

Credelio Quattro™ is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Credelio Quattro™ kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma Americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. Credelio Quattro™ is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Credelio Quattro™

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

NexGard® PLUS

For the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. It is also indicated for the treatment and control of the following intestinal parasites: adult, immature adult and fourth stage larvae in hookworm species (Ancylostoma caninum and Uncinaria stenocephala); adult and fourth stage larvae in roundworm species (Toxocara canis); and adult stage in roundworm species (Toxascaris leonina) and whipworm (Trichuris vulpis).

PARASEDGE® Multi for Dogs

For the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis); for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis; and for the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis).

Midamox® for Dogs

For the prevention of heartworm disease caused by Dirofilaria immitis; and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; and the treatment and control of intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum and Uncinaria stenocephala), and whipworms (Trichuris vulpis); kills adult fleas and treats flea infestations (Ctenocephalides felis); treats and controls sarcoptic mange caused by Sarcoptes scabiei var. canis.

Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats.

Advantage Multi™ for Dogs

For the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater.

Credelio Quattro™-CA1

To prevent infection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm disease.

Use once-a-month in dogs at 8 weeks of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ProHeart™

For treatment of existing larval and adult hookworm (Ancylostoma caninum and Unicinaria stenocephala) infections.

Do not administer ProHeart 6 to dogs who are sick, debilitated, underweight or who have a history of weight loss. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment. Do not overdose growing puppies in anticipation of their expected adult weight. No more than 3 mL should be administered in a single site. ProHeart 6 should not be used more frequently than every 6 months. The safety and eff ectiveness of ProHeart 6 has not been evaluated in dogs less than 6 months of age. Caution should be used when administering ProHeart 6 to heartworm positive dogs.

ProHeart® 6

For prevention of heartworm disease caused by Dirofilaria immitis.

Do not administer ProHeart 6 to dogs who are sick, debilitated, underweight or who have a history of weight loss. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment. Do not overdose growing puppies in anticipation of their expected adult weight. No more than 3 mL should be administered in a single site. ProHeart 6 should not be used more frequently than every 6 months. The safety and eff ectiveness of ProHeart 6 has not been evaluated in dogs less than 6 months of age. Caution should be used when administering ProHeart 6 to heartworm positive dogs.

ProHeart® 6

Dogs (Dogs and Puppies At Least 7 Weeks of Age)

For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of Ancylostoma caninum (adults, immature adults, and fourth stage larvae), Uncinaria stenocephala (adults, immature adults, and fourth stage larvae), Toxocara canis (adults and fourth stage larvae), Toxascaris leonina (adults), and Trichuris vulpis (adults) in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 pounds.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CORAXIS™

Dogs 1 year of age and older

For use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months. For the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.

ProHeart® 12

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

BRAVECTO® PLUS

For the prevention of heartworm disease caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. It is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites: adult, immature adult, and fourth stage larvae in hookworms (Ancyclostoma tubaeforme); and adult and fourth stage larvae in roundworms (Toxacara cati).

PARASEDGE™ Multi for Cats

For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. It is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations, intestinal roundworms (Toxocara cati), and hookworms (Ancylostoma tubaeforme).

Midamox® for Cats

For the prevention of heartworm disease caused by Dirofilaria immitis; for the treatment and control of ear mite (Otodectes cynotis) infestations, intestinal roundworms (Toxocara cati), and hookworms (Ancylostoma tubaeforme); kills adult fleas and treats flea infestations (Ctenocephalides felis).

Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick, debilitated, or underweight cats. Do not use on cats less than 9 weeks of age or less than 2 lbs. body weight. Do not apply to irritated skin.

advantage multi™ for cats

Cattle (Beef and Non-Lactating Dairy)

For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), T. colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), C. pectinate (adults), C. punctate (adults and fourth-stage larvae), C. spatulata (adults), C. surnabad (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparous (adults and fourth-stage larvae); grubs: Hypoderma bovis and H. lineatum; mites: Psoroptes ovis (P. communis var. bovis); lice: Linognathus vituli and Solenopotes capillatus; for protection of cattle from reinfection with D. viviparous and O. radiatum for 42 days after treatment, with H. placei for 35 days after treatment, and with O. ostertagi and T. axei for 14 days after treatment.

Do not slaughter cattle within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.

Cydectin®

Beef and Dairy Cattle

For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus, adult and L4); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola(Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.

A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

Cydectin™ (moxidectin) Pour-On for Beef and Dairy Cattle

Beef and nonlactating dairy cattle

For the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Ostertagia ostertagi – Adults and L4 (including inhibited Larvae) Haemonchus placei – Adults Trichostrongylus axei – Adults and L4 Trichostrongylus colubriformis – Adults and L4 Cooperia oncophora – Adults Cooperia pectinata – Adults Cooperia punctata – Adults and L4 Cooperia spatulata – Adults Cooperia surnabada – Adults and L4 Nematodirus helvetianus – Adults Oesophagostomum radiatum – Adults and L4 Trichuris spp. – Adults Lungworms Dictyocaulus viviparus – Adults and L4 Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Solenopotes capillatus Persistent Activity: Moxidectin Injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment.

Tauramox™

Beef and dairy cattle

For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.

MoxiShield™

Moxidectin Oral Drench for Sheep, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep: Parasites Haemonchus contortus - Adult and L4 Teladorsagia circumcincta - Adult and L4 Teladorsagia trifurcata - Adult and L4 Trichostrongylus axei - Adult and L4 Trichostrongylus colubriformis - Adult and L4 Trichostrongylus vitrinus - Adult and L4 Cooperia curticei - Adult and L4 Cooperia oncophora - Adult and L4 Oesophagostomum columbianum - Adult and L4 Oesophagostomum venulosum - Adult and L4 Nematodirus battus - Adult and L4 Nematodirus filicollis - Adult and L4 Nematodirus spathiger - Adult and L4

Moxidectin Oral Drench for Sheep

For the treatment and control of the adult and L4 larval stages of Haemonchus contortus, Teladorsagia circumcincta, T. trifurcate, Trichostrongylus axei, T. colubriformis, T. vitrines, Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. venulosum, Nematodirus battus, N. filicollis, and N. spathiger.

CYDECTIN Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Cydectin® Oral Drench for Sheep

Horses and Ponies

For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): (Cyathostomum species, including C. catinatum and C. pateratum; Cylicocyclus species, including C. insigne, C. leptostomum, C. nassatus and Cylicocyclus radiatus; Cylicostephanus species, including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Coronocyclus species, including C. coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and Petrovinema poculatus; small strongyles: undifferentiated luminal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days.

For oral use in horses and ponies 6 months of age and older. Do not use in horses intended for human consumption.QUEST PLUS Gel has been formulated specifically for use in horses and ponies only.Reproductive safety studies on breeding stallions have not been conducted.This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals.

Quest® Plus Gel

Horses and Ponies (6 Months of Age and Older)

For the treatment and control of the following stages of gastrointestinal parasites in horses and ponies: Large Strongyles: Strongylus vulgaris: (adults and L4 / L5 arterial stages), Strongylus edentatus: (adults and tissue stages), Triodontophorus brevicauda: (adults), Triodontophorus serratus: (adults) Small Strongyles (adults): Cyathostomum spp., including Cyathostomum catinatum, Cyathostomum pateratum Cylicostephanus spp., including Cylicostephanus calicatus, Cylicostephanus goldi, Cylicostephanus longibursatus, Cylicostephanus minutus Cylicocyclus spp., including Cylicocyclus insigne, Cylicocyclus leptostomum, Cylicocyclus nassatus, Cylicocyclus radiatus Coronocyclus spp., including Coronocyclus coronatus, Coronocyclus labiatus, Coronocyclus labratus, Gyalocephalus capitatus, Petrovinema poculatus Small Strongyles: Undifferentiated lumenal larvae Encysted cyathostomes: Late L3 and L4 mucosal cyathostome larvae Ascarids: Parascaris equorum: (adults and L4 larval stages) Pinworms: Oxyuris equi: (adults and L4 larval stages) Hairworms: Trichostrongylus axei: (adults) Large-mouth stomach worms: Habronema muscae: (adults) Horse stomach bots: Gasterophilus intestinalis: (2nd and 3rd instars), Gasterophilus nasalis: (3rd instars) One administration of the recommended dose rate of QUEST (moxidectin) 2% Equine Oral Gel also suppresses strongyle egg production through 84 days. QUEST is indicated for use in horses and ponies, including breeding mares and stallions, and foals six months of age and older.

QUEST 2% Equine Oral Gel has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result. Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.

Quest® Gel

For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets.

Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.

advantage multi™ for cats

QUEST (moxidectin) 2% Equine Oral Gel when administered at the recommended dose level of 0.4 mg moxidectin/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies: Large Strongyles: Strongylus vulgaris – (adults and L4/L5 arterial stages) Strongylus edentatus – (adults and tissue stages) Triodontophorus brevicauda – (adults) Triodontophorus serratus – (adults) Small Strongyles (adults): Cyathostomum spp., including Cyathostomum catinatum Cyathostomum pateratum Cylicostephanus spp., including Cylicostephanus calicatus Cylicostephanus goldi Cylicostephanus longibursatus Cylicostephanus minutus Cylicocyclus spp., including Cylicocyclus insigne Cylicocyclus leptostomum Cylicocyclus nassatus Cylicocyclus radiatus Coronocyclus spp., including Coronocyclus coronatus Coronocyclus labiatus Coronocyclus labratus Gyalocephalus capitatus Petrovinema poculatus Small Strongyles: Undifferentiated lumenal larvae Encysted cyathostomes Late L3 and L4 mucosal cyathostome larvae Ascarids Parascaris equorum – (adults and L4 larval stages) Pinworms Oxyuris equi – (adults and L4 larval stages) Hairworms Trichostrongylus axei – (adults) Large-mouth stomach worms Habronema muscae – (adults) Horse stomach bots Gasterophilus intestinalis – (2nd and 3rd instars) Gasterophilus nasalis – (3rd instars) One administration of the recommended dose rate of QUEST (moxidectin) 2% Equine Oral Gel also suppresses strongyle egg production through 84 days. QUEST is indicated for use in horses and ponies, including breeding mares and stallions, and foals six months of age and older.

QUEST® GEL (moxidectin)

INDICATIONS Moxidectin Injection, when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Ostertagia ostertagi - Adults and L4 (including inhibited Larvae) Haemonchus placei - Adults Trichostrongylus axei - Adults and L4 Trichostrongylus colubriformis - Adults and L4 Cooperia oncophora - Adults Cooperia pectinata - Adults Cooperia punctata - Adults and L4 Cooperia spatulata - Adults Cooperia surnabada - Adults and L4 Nematodirus helvetianus - Adults Oesophagostomum radiatum - Adults and L4 Trichuris spp. - Adults Lungworms Dictyocaulus viviparus - Adults and L4 Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Solenopotes capillatus Persistent Activity Moxidectin injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment. Management Considerations for External Parasites For most effective external parasite control, Moxidectin Injection (moxidectin) should be administered to all cattle in the herd. Cattle entering the herd following this administration should be treated prior to introduction. Consult your veterinarian or a livestock entomologist for the most appropriate time to administer Moxidectin Injection in your location to effectively control external parasites.

FDA application 200-788

CYDECTIN Injectable, when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Lungworms Ostertagia ostertagi - Adults and L4(including inhibited Larvae) Dictyocaulus viviparus - Adults and L4 Haemonchus placei - Adults Cattle Grubs Trichostrongylus axei - Adults and L4 Hypoderma bovis Trichostrongylus colubriformis - Adults and L4 Hypoderma lineatum Cooperia oncophora - Adults Mites Cooperia pectinata - Adults Psoroptes ovis Cooperia punctata - Adults and L4 (Psoroptes communis var. bovis) Cooperia spatulata - Adults Lice Cooperia surnabada - Adults and L4 Linognathus vituli Nematodirus helvetianus - Adults Solenopotes capillatus Oesophagostomum radiatum - Adults and L4 Trichuris spp. - Adults Persistent Activity: CYDECTIN Injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment. Management Considerations for External Parasites: For most effective external parasite control, CYDECTIN Injectable should be administered to all cattle in the herd. Cattle entering the herd following this administration should be treated prior to introduction. Consult your veterinarian or a livestock entomologist for the most appropriate time to administer CYDECTIN Injectable in your location to effectively control external parasites.

FDA application 141-220

QUEST PLUS Gel (moxidectin/praziquantel) when administered at the recommended dose level of 0.4 mg moxidectin/kg and 2.5 mg praziquantel/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies: Large Strongyles: Strongylus vulgaris – (adults and L4/L5 arterial stages) Strongylus edentatus – (adults and tissue stages) Triodontophorus brevicauda – (adults) Triodontophorus serratus – (adults) Small Strongyles(adults): Cyathostomumspp., including Cyathostomum catinatum Cyathostomum pateratum Cylicostephanus spp., including Cylicostephanus calicatus Cylicostephanus goldi Cylicostephanus longibursatus Cylicostephanus minutus Cylicocyclus spp., including Cylicocyclus insigne Cylicocyclus leptostomum Cylicocyclus nassatus Cylicocyclus radiatus Coronocyclusspp., including Coronocyclus coronatus Coronocyclus labiatus Coronocyclus labratus Gyalocephalus capitatus Petrovinema poculatus Small Strongyles: Undifferentiated lumenal larvae Encysted cyathostomes: Late L3 and L4 mucosal cyathostome larvae Ascarids: Parascaris equorum – (adults and L4 larval stages) Pinworms: Oxyuris equi – (adults and L4 larval stages) Hairworms: Trichostrongylus axei– (adults) Large-mouth stomach worms: Habronema muscae– (adults) Horse stomach bots: Gasterophilus intestinalis– (2nd and 3rd instars) Gasterophilus nasalis– (3rd instars) Tapeworms: Anoplocephala perfoliata – (adults) One administration of the recommended dose rate of QUEST PLUS Gel also suppresses strongyle egg production through 84 days.

QUEST® PLUS GEL (moxidectin/praziquantel)

Credelio Quattro is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. Credelio Quattro is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Credelio Quattro-CA1 is indicated for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater.

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

Tauramox™ Injectable, when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of the following internal and external parasites of cattle: Gastrointestinal Roundworms Lungworms Ostertagia ostertagi - Adults and L4 (including inhibited Larvae) Haemonchus placei - Adults Trichostrongylus axei - Adults and L4 Trichostrongylus colubriformis - Adults and L4 Cooperia oncophora - Adults Cooperia pectinata - Adults Cooperia punctata - Adults and L4 Cooperia spatulata - Adults Cooperia surnabada - Adults and L4 Nematodirus helvetianus - Adults Oesophagostomum radiatum - Adults and L4 Trichuris spp.- Adults Dictyocaulus viviparus - Adults and L4 Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Solenopotes capillatus Persistent Activity: Moxidectin Injectable has been proven to effectively protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, Haemonchus placei for 35 days after treatment, and Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment.

Tauramox™(moxidectin)Injectable Solution for Beefand Nonlactating Dairy Cattle

SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. SIMPARICA TRIO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. SIMPARICA TRIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Simparica TRIO®

Indications: MoxiSolv Pour-On when applied at the recommended dose level of 0.5 mg/2.2 lb (0.5 mg/kg) body weight is effective in the treatment and control of the following internal [adult and fourth-stage larvae (L4)] and external parasites of cattle: Gastrointestinal Roundworms Ostertagia ostertagi - Adult and L4 (including inhibited larvae) Haemonchus placei - Adult and L4 Trichostrongylus axei - Adult and L4 Trichostrongylus colubriformis - Adult and L4 Cooperia oncophora - Adult and L4 Cooperia pectinata - Adult Cooperia punctata - Adult and L4 Cooperia spatulata – Adult Cooperia surnabada - Adult and L4 Bunostomum phlebotomum - Adult Nematodirus helvetianus - Adult and L4 Oesophagostomum radiatu m - Adult and L4 Lungworms Dictyocaulus viviparus - Adult and L4 Cattle Grubs Hypoderma bovis Hypoderma lineatum Mites Chorioptes bovis Psoroptes ovis (Psoroptes communis var. bovis) Lice Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Bovicola (Damalinia) bovis Horn Flies Haematobia irritans

FDA application 200-845

NexGard® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. NexGard® PLUS kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick) and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. NexGard® PLUS is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

IMOXI™ Topical Solution for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. IMOXI™ Topical Solution for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). IMOXI™ Topical Solution for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. IMOXI™ Topical Solution for Dogs is also indicated for the treatment and control of the following intestinal parasites: Intestinal Parasite Intestinal Stage Adult Immature Adult Fourth Stage Larvae Hookworm Species Ancylostoma caninum X X X Uncinaria stenocephala X X X Roundworm Species Toxocara canis X X Toxascaris leonina X Whipworm Trichuris vulpis X

IMOXI™ Topical Solution for Dogs (imidacloprid + moxidectin)

Durvet Moxidectin Oral Sheep Drench, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep: Parasites Haemonchus contortus – Adult and L4 Teladorsagia circumcincta – Adult and L4 Teladorsagia trifurcata – Adult and L4 Trichostrongylus axei – Adult and L4 Trichostrongylus colubriformis – Adult and L4 Trichostrongylus vitrinus – Adult and L4 Cooperia curticei – Adult and L4 Cooperia oncophora – Adult and L4 Oesophagostomum columbianum – Adult and L4 Oesophagostomum venulosum – Adult and L4 Nematodirus battus – Adult and L4 Nematodirus filicollis – Adult and L4 Nematodirus spathiger – Adult and L4

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

CYDECTIN Oral Drench for Sheep, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep: Parasites Haemonchus contortus - Adult and L4 Cooperia oncophora - Adult and L4 Teladorsagia circumcincta - Adult and L4 Oesophagostomum columbianum - Adult and L4 Teladorsagia trifurcata - Adult and L4 Oesophagostomum venulosum - Adult and L4 Trichostrongylus axei - Adult and L4 Nematodirus battus - Adult and L4 Trichostrongylus colubriformis - Adult and L4 Nematodirus filicollis - Adult and L4 Trichostrongylus vitrinus - Adult and L4 Nematodirus spathiger - Adult and L4 Cooperia curticei - Adult and L4

FDA application 141-247

Bravecto Plus is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Bravecto Plus kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Haemaphysalis longicornis (Asian longhorned tick), and Amblyomma maculatum (Gulf Coast tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

INDICATIONS: IMOXI™ Topical Solution for Cats is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. IMOXI™ Topical Solution for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. IMOXI™ Topical Solution for Cats is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites: Intestinal Parasite Intestinal Stage Adult Immature Adult Fourth Stage Larvae Hookworm Species Ancylostoma tubaeforme X X X Roundworm Species Toxocara cati X X

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

PARASEDGE™ Multi for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. PARASEDGE™ Multi for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis).PARASEDGE™ Multi for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis.PARASEDGE™ Multi for Dogs is also indicated for the treatment and control of the following intestinal parasites:

PARASEDGE™ Multi for Dogs(imidacloprid + moxidectin) Topical Solution

103963B Once-a-month topical solution for the prevention of heartworm disease, the treatment of circulating microfilariae, kills adult fleas, is indicated for the treatment of flea infestations, the treatment and control of sarcoptic mange, as well as the treatment and control of intestinal parasite infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

IMOXI™ Topical Solution for Dogs (imidacloprid + moxidectin)

PARASEDGE™ Multi for Cats is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. PARASEDGE™ Multi for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. PARASEDGE™ Multi for Cats is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites:

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

Once-a-month topical solution for cats for the prevention of heartworm disease, kills adult fleas, is indicated for the treatment of flea infestations, as well as the treatment and control of ear mite infestations and intestinal parasite infections in cats and kittens 9 weeks of age and older and that weigh at least 2 lbs.

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

ProHeart 12 is indicated for use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months. ProHeart 12 is indicated for the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

For ferrets: PARASEDGE Multi for Cats is indicated for the prevention of heartworm disease in ferrets caused by Dirofilaria immitis. PARASEDGE Multi for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets.

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

Mechanism of Action Credelio Quattro contains four active pharmaceutical ingredients, lotilaner, moxidectin, praziquantel, and pyrantel (as pamoate salt). Lotilaner is an ectoparasiticide belonging to the isoxazoline group. Lotilaner inhibits insect and acarine gamma-aminobutyric acid (GABA)-gated chloride channels. This inhibition blocks the transfer of chloride ions across cell membranes, which results in uncontrolled neuromuscular activity leading to death of insects and acarines. The selective toxicity of lotilaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors. Moxidectin is an endectocide in the macrocyclic lactone class. Moxidectin acts by interfering with the chloride channel-mediated neurotransmission in the parasite. This results in paralysis and death of the parasite. Praziquantel’s mode of action is not precisely known, but treated tapeworms undergo muscular paralysis accompanied by a rapid influx of calcium ions and the disruption of the tegument. Pyrantel is a nematocide belonging to the tetrahydropyrimidine class. Pyrantel acts as a depolarizing, neuromuscular-blocking agent in susceptible parasites, causing paralysis and death or expulsion of the parasite. Pharmacokinetics Due to reduced drug bioavailability of lotilaner in the fasted state, Credelio Quattro must be administered with a meal or within 30 minutes after feeding. Following a single oral administration of Credelio Quattro at the minimum labeled dose in the fed state or a single intravenous administration of 5 mg lotilaner, 0.005 mg moxidectin, 1.25 mg praziquantel, and 1.25 mg pyrantel per kg body weight to Beagle dogs (1.5 to 2.5 years old), the mean oral bioavailability for lotilaner, praziquantel, and pyrantel was 93%, 41%, and 31%, respectively. Bioavailability for moxidectin is not reported due to insufficient data to adequately describe the elimination phase following intravenous administration. For Credelio Quattro, the area under the curve from time of dosing to the time of the last measurable concentration (AUClast) was 5970, 1.75, 1.54, and 0.857 mg*h/L for lotilaner, moxidectin, praziquantel, and pyrantel, respectively. Peak concentrations (Cmax) of 9070, 15.3, 390, and 122 ng/mL were reached (Tmax) 10, 4.5, 0.75, and 2.5 h after dosing for lotilaner, moxidectin, praziquantel, and pyrantel, respectively. Mean plasma elimination half‐lives were 806, 634, 3.64, and 4.87 h for lotilaner, moxidectin, praziquantel, and pyrantel, respectively. Following nine oral administrations of Credelio Quattro at 1X, 3X, and 5X the maximum labeled dose of 40 mg/kg lotilaner, 0.04 mg/kg moxidectin, 10 mg/kg praziquantel, and 10 mg/kg pyrantel, every 28 days in 8-week-old Beagle dogs, moxidectin and lotilaner area under the curve from time of dosing to the time of the last measurable concentration (AUClast) increased approximately in a less than proportional manner, whereas praziquantel AUClast increased approximately in a more than proportional manner from 1X to 5X after most study doses. Pyrantel AUClast increased approximately in a proportional manner from 1X to 5X observed after first, sixth, and last doses. Within the 1X group, accumulation was observed between Days 0 and 224 with geometric mean accumulation ratios for AUClast of 6.2 and 7.9 for lotilaner and moxidectin, respectively. Concentrations of praziquantel and pyrantel prior to each dose were below the limit of quantification.

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

Mode of Action: NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) contains the three active pharmaceutical ingredients afoxolaner, moxidectin, and pyrantel (as pamoate salt). Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and postsynaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors. Moxidectin is an endectocide in the macrocyclic lactone class. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in susceptible parasites, which results in paralysis and death of the parasite. Pyrantel is a nematocide belonging to the tetrahydropyrimidine class. Pyrantel acts as a depolarizing, neuromuscular-blocking agent in susceptible parasites, causing paralysis and death or expulsion of the parasite. Pharmacokinetics: Following a single oral administration of a near-final formulation of NexGard® PLUS (at mean doses of 3.9 mg/kg afoxolaner, 18.8 mcg/kg moxidectin, and 7.8 mg/kg pyrantel pamoate) in fed and fasted Beagle dogs (10 to 21 months of age), afoxolaner and moxidectin were more rapidly absorbed in the fasted state with a time to maximum concentration (Tmax) of 2 to 3 hours. The afoxolaner mean maximum plasma concentrations (Cmax) in the fed and fasted states were 1610 and 2200 ng/mL (CV=33 and 16%) and the moxidectin mean Cmax values were 11.1 and 15.5 ng/mL (CV=39 and 24%), respectively. The area under the curve (AUC) for afoxolaner and moxidectin were similar between fed and fasted states. Post-dose pyrantel plasma concentrations were quantifiable out to 24 hours. Following six oral administrations of NexGard® PLUS at 1, 3, and 5X the maximum exposure dose of 5 mg/kg, 24 mcg/kg, and 10 mg/kg afoxolaner, moxidectin, and pyrantel pamoate, respectively, every 28 days in 8-week-old Beagle dogs, afoxolaner and moxidectin Tmax ranged from 2 to 6 hours. The observed mean Cmax and AUC at steady state in the 1X dose group were 2230 ng/mL and 19000 days*ng/mL for afoxolaner and 14.8 ng/mL and 55.2 days*ng/mL for moxidectin, respectively. Based on mean Cmin, afoxolaner and moxidectin accumulated by less than 4-fold at steady state. Afoxolaner and moxidectin exposure increased in a dose proportional manner between the 1X and 3X dose groups but was less than dose proportional in the 5X dose group. Pyrantel pamoate is poorly absorbed into systemic circulation. Pyrantel pamoate is intended to remain in the gastrointestinal tract to allow effective concentrations to be delivered to gastrointestinal nematodes.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

Following oral administration of SIMPARICA TRIO in Beagle dogs (13 to 15 months of age at the time of initial dosing), sarolaner and moxidectin were rapidly and well-absorbed. Following a single oral dose of SIMPARICA TRIO (sarolaner dose of 1.2 mg/kg), the sarolaner mean maximum plasma concentration (Cmax) was 523 ng/mL with a mean time to maximum concentration (Tmax) of 3.5 hours and an absolute bioavailability of 88%. At a moxidectin dose of 0.024 mg/kg, the moxidectin mean Cmax was 13.1 ng/mL with a mean Tmax of 2.4 hours and an absolute bioavailability of 67%. Following intravenous (IV) dosing of a combination solution of sarolaner and moxidectin, the sarolaner volume of distribution (Vss) was 2.4 L/kg and systemic clearance (CL) was 6.0 mL/kg/hr. For moxidectin the Vss was 7.65 L/kg and CL was 26.6 mL/kg/hr. The terminal half‑lives were similar after oral and IV dosing for both sarolaner (12 days) and moxidectin (11 days). The primary route of elimination of both sarolaner and moxidectin is biliary excretion with minimal metabolism. Following an oral dose of SIMPARICA TRIO containing 5 mg/kg pyrantel (as pamoate salt), pyrantel has measurable plasma concentrations, but they are low and highly variable. Pyrantel pamoate is intended to remain in the gastrointestinal tract allowing for delivery of effective concentrations to gastrointestinal nematodes.

Simparica TRIO®

Moxidectin is a semi-synthetic methoxime derivative of nemadectin which is a fermentation product of Streptomyces cyaneogriseus subspecies noncyanogenus. Moxidectin is a pentacyclic 16-membered lactone macrolide. Moxidectin has activity resulting in paralysis and death of affected parasites. The stage of the canine heartworm affected at the recommended dose rate of 0.5 mg/kg (0.23 mg/lb) is the tissue larval stage. The larval and adult stages of the canine hookworms, A. caninum and U. stenocephala, are susceptible. Following injection with ProHeart 12, peak moxidectin blood levels will be observed approximately 7-14 days after treatment. At the end of the 12-month dosing interval, residual drug plasma concentrations are negligible. Accordingly, little or no drug accumulation is expected to occur with repeated administrations.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. Peak moxidectin concentrations are achieved between 1 and 5 days following topical administration and the elimination half-life ranges between 20 and 30 days.

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

Do not administer this product orally. (See WARNINGS.) Do not use this product (containing 2.5 % moxidectin) on cats.

PARASEDGE™ Multi for Dogs(imidacloprid + moxidectin) Topical Solution

ProHeart 12 is contraindicated in animals previously found to be hypersensitive to this drug or ProHeart 6.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

There are no known contraindications for the use of Credelio Quattro/Credelio Quattro-CA1.

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

There are no known contraindications for the use of SIMPARICA TRIO.

Simparica TRIO®

There are no known contraindications for the use of NexGard® PLUS.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

There are no known contraindications for the use of the product.

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

Margin of Safety: NexGard® PLUS was administered orally at 1, 3, and 5X the maximum exposure doses at approximately 28-day intervals for six treatments to 8-week-old Beagle puppies. Dogs in the control group were sham-dosed. There were no clinically relevant, treatment-related effects on body weights, food consumption, clinical pathology (hematology, coagulation, serum chemistry, and urinalysis), gross pathology, histopathology, organ weights, or ophthalmic examinations. Mild, self-limiting diarrhea (with and without blood) was possibly related to treatment, as there were more incidences in the NexGard® PLUS groups than the control group throughout the study, including within 48 hours after treatment. Avermectin-Sensitive Collie Safety: NexGard® PLUS was administered orally at 1, 3, and 5X the maximum label dose to MDR1-deficient Collies once on Day 0, with a second administration to the 1X group on Day 28. Dogs in the control group were sham-dosed on Days 0 and 28. No clinical signs of avermectin toxicity were noted in any dog at any time during the study. Vomiting was observed in some dogs in the 3X and 5X groups and resolved without treatment. Diarrhea, with or without blood, was observed in some dogs in all of the NexGard® PLUS groups and resolved without treatment. Heartworm-Positive Safety: NexGard® PLUS was administered orally at 1X and 3X the maximum exposure doses at approximately 28-day intervals for three treatments to Beagle dogs with adult heartworm infections and circulating microfilariae. Dogs in the control group were sham-dosed. Diarrhea was observed in one dog in the 1X group and in three dogs in the 3X group, and vomiting was observed in two dogs in the 3X group. No signs of avermectin toxicity were observed at any time during the study. There were no clinical signs associated with death of the microfilariae observed in any of the dogs. Field Safety: In a well-controlled field study, NexGard® PLUS was used concurrently with other medications such as vaccines, antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), anesthetics, sedatives, analgesics, steroids, anthelmintics, antiemetics, and antipruritics. No adverse reactions were associated with the concurrent use of NexGard® PLUS and other medications.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

HUMAN WARNINGS: Not for human use. Keep out of the reach of children. Children should not come in contact with the application site for 30 minutes after application. Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly with soap and warm water after handling. If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice. The Safety Data Sheet (SDS) provides additional occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Vetoquinol USA at 1-800-835-9496 or www.vetoquinolusa.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

ANIMAL SAFETY WARNINGS Do not use in sick, debilitated, or underweight animals. In foreign countries there have been reports of adverse effects, including death. This product should not be used in calves less than 8 weeks of age because safety testing has not been done in the U.S. in calves less than 8 weeks of age. ENVIRONMENTAL WARNINGS Studies indicate that when moxidectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Free moxidectin may adversely affect fish and certain aquatic organisms. Do not contaminate water by direct application or by improper disposal of drug containers. OTHER WARNINGS Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

FDA application 200-788

Not for human use. Keep out of the reach of children. Children should not come in contact with application sites for two (2) hours after application. Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly with soap and warm water after handling. If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice. The Safety Data Sheet (SDS) provides additional occupational safety information. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.

Elanco TM advantage multi™ for dogs (imidacloprid+moxidectin) Topical Solution

•Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. •Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. •Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). •A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring. •Macrocyclic lactones provide prolonged drug exposure that may increase selection pressure for resistant parasites. This effect may be more pronounced in extended-release formulations.

FDA application 141-247

For the first 30 minutes after application: Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs, and Separate treated dogs from one another and from other pets to reduce the risk of accidental ingestion. Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors. In avermectin sensitive dogs, a the signs may be more severe and may include coma and death. b a Some dogs are more sensitive to avermectins due to a mutation in the MDR1 gene. Dogs with this mutation may develop signs of severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and Collie crosses. b Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from avermectin toxicity with intensive veterinary supportive care.

Midamox® for Dogs(imidacloprid + moxidectin)Topical Solution

Warning: Not For Use In Humans. Keep this and all drugs out of the reach of children. This product can cause irritation to skin, eyes, or mucous membranes. In case of accidental skin contact and/or clothing contamination, wash skin thoroughly with soap and water and launder clothing with detergent. In case of accidental eye contact, flush eyes with copious amounts of water. When direct inhalation occurs, cleanse lungs and respiratory passages with fresh air. In case of ingestion do not induce vomiting and seek medical attention immediately. If irritation or any other symptom attributable to exposure to this product persists, consult your physician. CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae

FDA application 200-845

Not for human use. Keep this and all drugs out of the reach of children. Do not contact or allow children to contact the application site until 2 hours post application. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If contact with eyes occurs, then flush eyes slowly and gently with water. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing, then seek medical advice immediately. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. If the product accidentally contacts skin and a sticky residue persists after washing, rubbing alcohol (70% isopropyl alcohol) can be applied to the area to remove the residue. The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

Not For Use In Humans. Keep this and all drugs out of the reach of children. This product can cause irritation to skin, eyes, or mucous membranes. In case of accidental skin contact and/or clothing contamination, wash skin thoroughly with soap and water and launder clothing with detergent. In case of accidental eye contact, flush eyes with copious amounts of water. When direct inhalation occurs, cleanse lungs and respiratory passages with fresh air. In case of ingestion do not induce vomiting and seek medical attention immediately. If irritation or any other symptom attributable to exposure to this product persists, consult your physician. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 1-800-428-4441.

FDA application 141-099

Anaphylactic and anaphylactoid reactions may occur in some dogs following administration of ProHeart 12 alone or with vaccines. In some cases, these reactions have resulted in death following administration of moxidectin microspheres (see POST-APPROVAL EXPERIENCE). Anaphylactic and anaphylactoid reactions should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products. Always provide Client Information Sheet and review with owners before administering ProHeart 12. The owner should be advised to observe their dog for adverse drug events including those described on the sheet. Do not administer ProHeart 12 to dogs who are sick, debilitated, underweight or who have a history of weight loss.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

Not for human use. Keep this and all drugs out of the reach of children. If contact with your skin occurs, wash thoroughly with water. May be irritating to the eyes. If product accidentally gets into your eyes, flush eyes thoroughly with water. In case of accidental ingestion, or if skin or eye irritation occurs, contact a Poison Control Center or physician for treatment advice and show the package insert to the physician. Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice and show the package insert or the label to the physician. The Safety Data Sheet (SDS) contains more detailed occupational safety information.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

Not for human use. Keep this and all drugs out of the reach of children. May be slightly irritating to the eyes. May cause slight irritation to the upper respiratory tract if inhaled. May be harmful if swallowed. If contact with the eyes occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. If accidental ingestion occurs, contact a Poison Control Center or a physician immediately. The Safety Data Sheet (SDS) contains more detailed occupational safety information.

ProHeart® 6 (moxidectin)For Extended-Release Injectable Suspension for Dogs

HUMAN WARNINGS Not For Use in Humans. Keep this and all drugs out of the reach of children CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae

FDA application 200-788

RESIDUE WARNINGS Cattle must not be slaughtered for human consumption within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.

FDA application 200-788

Not for use in humans. Keep this and all drugs out of the reach of children. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

Residue Warning: When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time are required. Meat and milk from cattle treated with MoxiSolv Pour-On (moxidectin) may be used for human consumption at any time following treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA application 200-845

When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time are required. Meat and milk from cattle treated with CYDECTIN (moxidectin) Pour-On may be used for human consumption at any time following treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

FDA application 141-099

Not for use in humans. Keep this and all drugs out of the reach of children. Questions/Comments? For product questions, to report side effects, or for a copy of the Safety Data Sheet (SDS), contact Elanco Product & Veterinary Support at 1-800-428-4441. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

FDA application 141-247

Not For Use in Humans. Keep this and all drugs out of the reach of children. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 1-800-428-4441. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

FDA application 141-220

Not for use in humans. Keep this and all drugs out of the reach of children. Do not ingest. If swallowed, induce vomiting. Wash hands and contaminated skin with soap and water. If accidental contact with eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product persists, consult your physician.

QUEST® GEL (moxidectin)

Durvet Moxidectin Oral Sheep Drench has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

CYDECTIN Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

FDA application 141-247

Not for use in humans. Keep this and all drugs out of reach of children. Wash hands after handling. If accidentally ingested, seek medical attention immediately. Keep Credelio Quattro/Credelio Quattro-CA1 in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

Do not use in sick, debilitated, or underweight animals. In foreign countries there have been reports of adverse effects, including death. This product should not be used in calves less than 8 weeks of age because safety testing has not been done in the U.S. in calves less than 8 weeks of age.

FDA application 141-220

Not for use in humans. Keep this and all drugs out of the reach of children. In case of accidental ingestion, contact a physician for treatment advice. Keep NexGard® PLUS in a secure location out of the reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.

QUEST® GEL (moxidectin)

RESIDUE WARNINGS: Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.

FDA application 141-247

Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

Not for use in humans. Keep this and all drugs out of reach of children. Keep SIMPARICA TRIO in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.

Simparica TRIO®

WARNINGS: Do not use on sick, debilitated, or underweight cats (see ADVERSE REACTIONS). Do not use on cats less than 9 weeks of age or less than 2 lbs. body weight.

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

Do not use on sick or debilitated ferrets.

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

Heartworm-Negative Dogs Field Studies: Following treatment with imidacloprid and moxidectin topical solution or an active control, dog owners reported the following post-treatment reactions: During a field study using 61 dogs with pre-existing flea allergy dermatitis, one (1.6%) dog experienced localized pruritus immediately after imidacloprid application, and one investigator noted hyperkeratosis at the application site of one dog (1.6%). In a field safety and effectiveness study, imidacloprid and moxidectin topical solution was administered to 92 client-owned dogs with sarcoptic mange. The dogs ranged in age from 2 months to 12.5 years and ranged in weight from 3 to 231.5 pounds. Adverse reactions in dogs treated with imidacloprid and moxidectin topical solution included hematochezia, diarrhea, vomiting, lethargy, inappetence, and pyoderma. Laboratory Effectiveness Studies: One dog in a laboratory effectiveness study experienced weakness, depression, and unsteadiness between 6 and 9 days after application with imidacloprid and moxidectin topical solution. The signs resolved without intervention by day 10 post-application. The signs in this dog may have been related to peak serum levels of moxidectin, which vary between dogs, and occur between 1 and 21 days after application of imidacloprid and moxidectin topical solution. The following clinical observations also occurred in laboratory effectiveness studies following application with imidacloprid and moxidectin topical solution and may be directly attributed to the drug or may be secondary to the intestinal parasite burden or other underlying conditions in the dogs: diarrhea, bloody stools, vomiting, anorexia, lethargy, coughing, ocular discharge and nasal discharge. Observations at the application sites included damp, stiff or greasy hair, the appearance of a white deposit on the hair, and mild erythema, which resolved without treatment within 2 to 48 hours. Heartworm-Positive Dogs Field Study: A 56-day field safety study was conducted in 214 D. immitis heartworm and microfilaria positive dogs with Class 1, 2 or 3 heartworm disease. All dogs received imidacloprid and moxidectin topical solution on Study Days 0 and 28; 108 dogs also received melarsomine dihydrochloride on Study Days -14, 14 and 15. All dogs were hospitalized for a minimum of 12 hours following each treatment. Effectiveness against circulating D. immitis microfilariae was > 90% at five of six sites; however, one site had an effectiveness of 73.3%. The microfilaria count in some heartworm-positive dogs increased or remained unchanged following treatment with imidacloprid and moxidectin topical solution alone or in a dosing regimen with melarsomine dihydrochloride. Following treatment with imidacloprid and moxidectin topical solution alone or in a dosing regimen with melarsomine dihydrochloride, the following adverse reactions were observed: Three dogs treated with imidacloprid and moxidectin topical solution ina dosing regimen with melarsomine dihydrochloride died of pulmonary embolism from dead and dying heartworms. One dog, treated with imidacloprid and moxidectin topical solution and melarsomine dihydrochloride, experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with imidacloprid and moxidectin topical solution alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In both groups, there were more adverse reactions to imidacloprid and moxidectin topical solution following the first treatment than the second treatment. To report a suspected adverse reaction, call 1-800-338-3659. Post-Approval Experience The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events in dogs are listed in decreasing order of reporting frequency: depression/lethargy, vomiting, pruritus, diarrhea, anorexia, hyperactivity, ataxia, trembling, hypersalivation, application site reactions (alopecia, pruritus, lesions, and erythema), seizures, and anaphylaxis/anaphylactic reactions (hives, urticaria, facial swelling, edema of the head). Serious reactions, including neurologic signs and death have been reported when cats have been exposed (orally and topically) to this product. In humans, nausea, numbness or tingling of the mouth/lips and throat, ocular and dermal irritation, pruritus, headache, vomiting, diarrhea, depression and dyspnea have been reported following exposure to this product. To report suspected adverse events and/or obtain a copy of the SDS or for technical assistance, call VIRBAC AH, Inc. at 1-800-338-3659. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

PARASEDGE™ Multi for Dogs(imidacloprid + moxidectin) Topical Solution

A well-controlled field study was conducted, including a total of 593 dogs (297 received two doses of ProHeart 12, 12 months apart and 296 received a monthly oral heartworm preventive as active control) ranging in age from 1 to 14 years. Over the 605-day study period, all observations of potential adverse reactions were recorded. Table 2: Number of Dogs* with Adverse Reactions Reported During the ProHeart 12 Field Study Adverse Reaction ProHeart® 12 n=297 (%) Active Control n=296 (%) Vomiting 75 (25.3) 78 (26.4) Lethargy 46 (15.5) 34 (11.5) Diarrhea (with and without blood) 43 (14.5) 46 (15.5) Anorexia 41 (13.8) 31 (10.5) Seizures 10 (3.4) 7 (2.4) Hepatopathy 8 (2.7) 3 (1.0) Hypersalivation 7 (2.4) 3 (1.0) Anaphylactoid/Hypersensitivity Reactions 6 (2.0) 4 (1.4) *Some dogs may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. Two ProHeart 12 (moxidectin) - treated dogs experienced anaphylactoid/hypersensitivity-related clinical signs within the first 24 hours following the initial treatment. Both dogs responded to symptomatic treatment. One dog experienced hives and facial swelling that resolved in 24 hours. The second dog experienced redness and swelling of the face and paws, followed by vomiting, polydipsia, and elevated heart rate and was treated symptomatically. Signs resolved within 4 days. One dog was pre-treated before the second injection of ProHeart 12, and neither dog had a reaction to the second dose 12 months later. One active control-treated dog experienced anaphylactoid/hypersensitivity-related clinical signs within the first 24 hours. The dog was withdrawn from the study prior to the second monthly dose. Mild injection site reactions occurred in six ProHeart 12-treated dogs and were observed from one to seven days post dosing and included warmth, swelling and pruritus. One of these cases included mild pruritus at the injection site that resolved spontaneously within 24 hours of administration. In a laboratory effectiveness study, dogs with 4- and 6-month-old heartworm infections administered moxidectin microspheres at a dose of 0.17 mg/kg experienced vomiting, lethargy and bloody diarrhea. These signs were more severe in the dogs with 4-month-old heartworm infections, including one dog that was recumbent and required supportive care, than in the dogs with older (6-month-old) infections. Post-Approval Experience (2018): The following adverse events are based on post-approval adverse drug experience reporting for ProHeart 6. ProHeart 12 and ProHeart 6 are the same formulation, but ProHeart 12 is three times the concentration of ProHeart 6. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system. Immune: anaphylaxis and/or anaphylactoid reactions, urticaria, head/facial edema, pruritus, pale mucous membranes, collapse, cardiovascular shock, erythema, immune-mediated hemolytic anemia, immune-mediated thrombocytopenia (signs reflected in other system categories could be related to allergic reactions, i.e. gastrointestinal, dermatologic, and hematologic) Gastrointestinal: vomiting (with or without blood), diarrhea with or without blood, hypersalivation General: depression, lethargy, anorexia, fever, weight loss, weakness Dermatological: injection site pruritus/swelling, erythema multiforme Neurological: seizures, ataxia, trembling, hind limb paresis Hematological: leukocytosis, anemia, thrombocytopenia Respiratory: dyspnea, tachypnea, coughing Hepatic: elevated liver enzymes, hypoproteinemia, hyperbilirubinemia, hepatopathy Urinary: elevated BUN, elevated creatinine, hematuria, polydipsia, polyuria Cardiopulmonary signs such as coughing and dyspnea may occur in heartworm positive dogs. In some cases, death has been reported as an outcome of the adverse events listed above. Foreign market experience with ProHeart 12 includes similar voluntarily reported adverse events, including death, following administration of ProHeart 12. For a copy of the Safety Data Sheet (SDS) or to report suspected adverse reactions, contact Zoetis at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

In a field safety and effectiveness study, Credelio Quattro was administered to dogs for the prevention of heartworm disease. The study included a total of 372 dogs treated once monthly for up to 11 treatments (191 treated with Credelio Quattro and 181 treated with an active control). Over the 330-day study period, all observations of potential adverse reactions were recorded. Adverse reactions seen during the field study are summarized in the table below. Dogs with Adverse Reactions in the Field Study *Four dogs administered Credelio Quattro and five dogs administered the active control had bloody diarrhea. Clinical Sign Credelio Quattro N=191 Number (Percentage) Active Control N=181 Number (Percentage) Diarrhea, with or without blood* 21 (11%) 15 (8.3%) Vomiting 18 (9.4%) 8 (4.4%) Lethargy 12 (6.3%) 1 (0.6%) Anorexia 11 (5.8%) 5 (2.8%) Dermatitis 10 (5.2%) 8 (4.4%) Weight Loss 6 (3.1%) 3 (1.7%) Pruritus (itching) 3 (1.6%) 1 (0.6%) Alopecia (hair loss) 2 (1.0%) 4 (2.2%) Seizure 1 (0.5%) 4 (2.2%) Ataxia 1 (0.5%) 1 (0.6%) Nystagmus 1 (0.5%) 0 (0.0%) Anisocoria 1 (0.5%) 1 (0.6%) One geriatric dog receiving Credelio Quattro experienced two episodes of vomiting, ataxia, and nystagmus, 11 days apart, with the first episode occurring two days after the eighth dose. The dog recovered within 24 hours after the first episode and 1 hour after the second episode and completed the study. One dog receiving Credelio Quattro was observed by the investigator to have anisocoria during scheduled physical examinations one month after the ninth dose and one month after the eleventh dose. In a second U.S. field safety and effectiveness study, Credelio Quattro was administered to 103 dogs with hookworms. Adverse reactions in dogs treated with Credelio Quattro included gastrointestinal signs (diarrhea, emesis) and lethargy. In a U.S. field study, 165 dogs received a combination of lotilaner, moxidectin, and praziquantel, three of the active ingredients at the same doses as in Credelio Quattro, monthly for up to 11 months. Two dogs with no history of seizures experienced seizures during the study. One of the dogs developed cluster seizures and was removed from the study. Ataxia was also observed in one other dog three days after the first dose. In a U.S. field study, one dog administered lotilaner alone, a component of Credelio Quattro, was observed with intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of lotilaner. The head tremors resolved within 24 hours without treatment. The owner elected to withdraw the dog from the study. In an Australian field study, one dog with a history of seizures experienced seizure activity (tremors and glazed eyes) six days after receiving lotilaner alone. The dog recovered without treatment and completed the study. In a U.S. field study, two dogs with a history of seizures received lotilaner alone and experienced no seizures throughout the study.

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

Field Study: Following treatment with imidacloprid and moxidectin or an active control, cat owners reported the following post-treatment reactions: During another field study, a 16-year-old cat with renal disease slept in the same place without moving for two days following application. (See PRECAUTIONS.) Laboratory Effectiveness Studies: Imidacloprid and moxidectin was administered at the recommended dose to 215 cats in 20 effectiveness studies. One random-sourced cat exhibited signs consistent with either moxidectin toxicity or viral respiratory disease and died 26 hours after product application; necropsy findings were inconclusive as to the cause of death. A second cat that became ill 3 days after application of imidacloprid and moxidectin responded to treatment for respiratory infection and completed the study. A third cat became ill on day 3 and died with signs and lesions attributable to panleukopenia on day 7 after moxidectin application. Post-approval Experience: The following adverse events are based on post approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events in cats are listed in decreasing order of reporting frequency: hypersalivation, depression/lethargy, application site reactions (alopecia, pruritus, lesions, and erythema), decreased appetite, vomiting, hyperactivity, ataxia, trembling, and behavior disorder (hiding). In some cases death has been reported. In humans, ocular and dermal irritation, nausea, numbness or tingling of the mouth and lips, anaphylaxis, pruritus, vomiting, and tongue/taste abnormalities have been reported following exposure to this product. To report suspected adverse events and/or obtain a copy of the SDS or for technical assistance, call VIRBAC AH, Inc. at 1-800-338-3659. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

Field Safety Study in Ferrets: Imidacloprid and moxidectin was topically administered to 131 client-owned ferrets at the recommended dose volume (0.4 mL). The ferrets ranged in age from 3 months to 7 years, and weighed between 0.5 and 1.86 kg (1.1 to 4.1 lbs). The dose of imidacloprid ranged between 21.5 to 80.2 mg/kg in this study. The dose of moxidectin ranged between 2.2 to 8.0 mg/kg in this study. Adverse reactions in ferrets following treatment included: pruritus/scratching, scabbing, redness, wounds and inflammation at the treatment site; lethargy; and chemical odor. These adverse reactions resolved without additional therapy. Owners also reported stiffening of the hair at the treatment site, however, this is expected with application of a topical product and is not considered an adverse reaction. Three human adverse reactions were reported. An owner’s finger became red following skin contact with the product. One owner reported a headache caused by the chemical odor of the product. One owner reported a tingling sensation of the lips after kissing the treatment site. Foreign Market Experience: Because the following events were reported voluntarily during post-approval use of the product in foreign markets, it is not always possible to reliably establish a causal relationship to drug exposure. Adverse events reported in ferrets topically treated with 0.4 mL imidacloprid + moxidectin for cats included: malaise, vomiting, diarrhea, shaking, mydriasis, hypersalivation with abnormal neurologic signs, seizures, death, generalized hematoma of the body, and alopecia at the treatment site. Adverse reactions in humans included: burning, tingling, numbness, bad taste in the mouth, dizziness, and headache.

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

In a well-controlled U.S. field study, which included a total of 176 treated cats (135 with Bravecto Plus and 41 with a monthly topical active control), there were no serious adverse reactions. Percentage of Cats with Adverse Reactions (AR) in the Field Study Adverse Reaction Bravecto Plus Group: Percent of Cats with the AR During the 120-Day Study (n=135 cats) Active Control Group: Percent of Cats with the AR During the 120-Day Study (n=41 cats) Vomiting 5.9% 12.2% Alopecia (not at application site) 5.2% 2.4% Pruritus 4.4% 12.2% Application site pruritus 4.4% 4.9% Diarrhea 3.7% 7.3% Lethargy 3.7% 9.8% Dry Skin 3.0% 0.0% Elevated alanine aminotransferase (ALT)ALT was greater than twice the upper reference range of 100 IU/L. These cats also had mild elevations of aspartate aminotransferase (AST) (less than twice the upper reference range of 100 IU/L). No clinical signs associated with liver disease were noted in these cats. 3.0% 0.0% Hypersalivation 1.5% 1.5% Application site alopecia 0.7% 0.0% In well-controlled laboratory effectiveness studies, the following adverse reactions were seen after application of Bravecto Plus: pyrexia, tachypnea, mydriasis, pruritus, scabbing, and bloody stool.

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

In a field safety and effectiveness study, SIMPARICA TRIO was administered to dogs for the prevention of heartworm disease. The study included a total of 410 dogs treated once monthly for 11 treatments (272 treated with SIMPARICA TRIO and 138 treated with an active control). Over the 330-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the SIMPARICA TRIO group are presented in the following table. Table 1. Dogs with Adverse Reactions Clinical Sign SIMPARICA TRIO n = 272 Active Control n = 138 Vomiting 14.3% 10.9% Diarrhea 13.2% 8.0% Lethargy 8.5% 6.5% Anorexia 5.1% 5.8% Polyuria 3.7% 3.6% Hyperactivity 2.2% 0.7% Polydipsia 2.2% 2.9% In a second field safety and effectiveness study, SIMPARICA TRIO was administered to 278 dogs with fleas. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea. In a third field safety and effectiveness study, SIMPARICA TRIO was administered to 120 dogs with roundworms. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea and vomiting. In one well-controlled laboratory study, one dog had a seizure 16 days after administration of SIMPARICA TRIO.

Simparica TRIO®

In a field safety and effectiveness study, NexGard® PLUS was administered to dogs for the prevention of heartworm disease. The study included a total of 272 dogs (134 administered NexGard® PLUS and 138 administered active control) treated once monthly for 11 treatments. Over the 330-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the NexGard® PLUS group are presented in the following table. Table 1. Dogs With Adverse Reactions Clinical Sign NexGard® PLUS n = 134 Number (Percentage) Active Control n = 138 Number (Percentage) Diarrhea 9 (6.7%) 7 (5.1%) Vomiting 6 (4.5%) 7 (5.1%) Lethargy 3 (2.2%) 5 (3.6%) Itching 3 (2.2%) 3 (2.2%) Dermatitis 2 (1.5%) 1 (0.7%) Anorexia 1 (0.7%) 4 (2.9%) Muscle tremor 1 (0.7%) 1 (0.7%) One dog in the NexGard® PLUS group was reported to exhibit muscle tremors along with nausea and depression for one day after the Day 0 treatment. The dog remained in the study and muscle tremors were not reported after any subsequent treatments.

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

In field studies, the following adverse reactions were observed in dogs treated with ProHeart 6: anaphylaxis, vomiting, diarrhea (with and without blood), listlessness, weight loss, seizures, injection site pruritus, and elevated body temperature. Dogs with clinically significant weight loss (>10%) were more likely to experience a severe adverse reaction. In a laboratory effectiveness study, dogs with 4- and 6-month-old heartworm infections experienced vomiting, lethargy and bloody diarrhea. These signs were more severe in the dogs with 4-month-old heartworm infections, including one dog that was recumbent and required supportive care, than in the dogs with older (6-month-old) infections.

ProHeart® 6 (moxidectin)For Extended-Release Injectable Suspension for Dogs

ADVERSE REACTIONS:

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes.

Oral

NexGard® PLUS

Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

Oral

Credelio Quattro™

SimparicaTRIO® is given orally, once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 µg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

Oral

Simparica TRIO®

0.05 mL of the constituted suspension/kg body weight (0.0227 mL/lb). This amount of suspension will provide 0.17 mg per kilogram body weight (0.0773 mg per pound) as a single subcutaneous injection.

Subcutaneous

Do not administer ProHeart 6 to dogs who are sick, debilitated, underweight or who have a history of weight loss. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment. Do not overdose growing puppies in anticipation of their expected adult weight. No more than 3 mL should be administered in a single site. ProHeart 6 should not be used more frequently than every 6 months. The safety and eff ectiveness of ProHeart 6 has not been evaluated in dogs less than 6 months of age. Caution should be used when administering ProHeart 6 to heartworm positive dogs.

ProHeart® 6

The recommended minimum dose is 4.5 mg/lb. (10 mg/kg) imidacloprid and 1.1 mg/lb. (2.5 mg/kg) moxidectin, once a month, by topical administration.

Topical

IMOXI™ Topical Solution for Dogs

Apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg)moxidectin, once a month.

Topical

Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats.

Advantage Multi™ for Dogs

3 micrograms per kilogram (1.36 micrograms per pound) of body weight, once a month.

Oral

Use once-a-month in dogs at 8 weeks of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ProHeart™

Dogs (Dogs and Puppies At Least 7 Weeks of Age)

Administer topically a minimum of 1.1 mg/lb (2.5 mg/kg) of body weight, once monthly using the appropriate pre-loaded applicator tube.

Topical

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CORAXIS™

Dogs 1 year of age and older

The recommended subcutaneous dose is 0.05 mL of the constituted suspension/kg body weight (0.023 mL/lb). This amount of suspension will provide 0.5 mg moxidectin/kg body weight (0.23 mg/lb). To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment.

Subcutaneous

ProHeart® 12

Cattle (Beef and Non-Lactating Dairy)

0.2 mg/kilogram body weight (0.2 mg/2.2 pound) as a single subcutaneous injection.

Subcutaneous

Do not slaughter cattle within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.

Cydectin®

Beef and Dairy Cattle

The recommended rate of administration is 1 mL for each 22 lb (10 kg) of body weight which provides 5 mg moxidectin for each 22 lb (10 kg) of body weight.

Transdermal

A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

Cydectin™ (moxidectin) Pour-On for Beef and Dairy Cattle

Beef and nonlactating dairy cattle

Administer by subcutaneous injection 1 mL for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight.

Subcutaneous

Tauramox™

Beef and nonlactating dairy cattle

1 mL for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight.

Subcutaneous

MoxiSolv™ Injection

Beef and dairy cattle

Administer topically 0.5 mg per kilogram (kg) of body weight.

Topical

MoxiShield™

The recommended minimum dose for a ferret is 9 mg/lb (20 mg/kg) imidacloprid and 0.9 mg/lb (2mg/kg) moxidectin, once a month, by topical administration. Only the 0.4 mL applicator volume (Midamox 9) should be used on ferrets.

Topical

Midamox® for Cats

9 mg/lb (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month, by topical administration. Only the 0.4 mL applicator tube volume (PARASEDGE™ Multi 9) should be used on ferrets.

Topical

PARASEDGE™ Multi for Cats

The recommended minimum dose for a ferret is 9 m/lb (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month, by topical administration.

Topical

Barrier® for cats

Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

Topical

BRAVECTO® PLUS

The recommended minimum dose is 4.5 mg/lb. (10.0 mg/kg) imidacloprid and 0.45 mg/lb. (1.0 mg/kg) moxidectin, once a month, by topical administration.

Topical

IMOXI™ Topical Solution for Cats

Apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.

Topical

Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick, debilitated, or underweight cats. Do not use on cats less than 9 weeks of age or less than 2 lbs. body weight. Do not apply to irritated skin.

advantage multi™ for cats

The recommended rate of administration for Moxidectin Oral Drench for Sheep is 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of sheep, using any standard drenching equipment.

Oral

Moxidectin Oral Drench for Sheep

Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth.

Oral

CYDECTIN Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Cydectin® Oral Drench for Sheep

Horses and Ponies

Administer by mouth as a single dose: 0.4 milligram moxidectin per kilogram and 2.5 milligrams praziquantel per kilogram (2.2 pounds) body weight.

Oral

For oral use in horses and ponies 6 months of age and older. Do not use in horses intended for human consumption.QUEST PLUS Gel has been formulated specifically for use in horses and ponies only.Reproductive safety studies on breeding stallions have not been conducted.This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals.

Quest® Plus Gel

Horses and Ponies (6 Months of Age and Older)

0.4 mg moxidectin/ kg body weight

Oral

QUEST 2% Equine Oral Gel has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result. Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.

Quest® Gel

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. Remove the applicator from the outer pouch using scissors or fold along diagonal line to expose nick; tear back at nick. As specified in the following table, administer the entire contents of the Midamox for Dogs (imidacloprid and moxidectin) applicator that correctly corresponds with the body weight of the dog. * Dogs over 110 lbs. should be treated with the appropriate combination of Midamox for Dogs applicators. Dog (lbs.) Midamox for Dogs Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 Midamox 9 0.4 40 10 9.1–20 Midamox 20 1.0 100 25 20.1–55 Midamox 55 2.5 250 62.5 55.1–88 Midamox 88 4.0 400 100 88.1–110* Midamox 110 5.0 500 125 Hold the applicator upright. Tap the narrow part of the applicator to ensure the contents remain within the main body of the applicator. Twist or snap back the tip. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the applicator on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the applicator on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.) Contact with eyes can lead to eye irritation and corneal ulceration. If contact with eyes occurs, hold the dog's eyelids open, flush thoroughly with water, and contact your veterinarian. Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of Midamox for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Midamox for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas. Heartworm Prevention: For prevention of heartworm disease, Midamox for Dogs should be administered at one-month intervals. Midamox for Dogs may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer Midamox for Dogs immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with Midamox for Dogs should be given within one month of the last dose of the former medication. Treatment of Circulating Microfilaria: For the treatment of circulating D. immitis microfilaria in heartworm-positive dogs, Midamox for Dogs should be administered at one-month intervals. Treatment with an approved adulticide therapy is recommended because Midamox for Dogs is not effective for the treatment of adult D. immitis. (See PRECAUTIONS.)

TOPICAL

Midamox® for Dogs(imidacloprid + moxidectin)Topical Solution

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. Do not let this product get in your dog’s mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.) Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of PARASEDGE™ Multi for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of PARASEDGE™ Multi for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas. Heartworm Prevention: For prevention of heartworm disease, PARASEDGE™ Multi for Dogs should be administered at one-month intervals. PARASEDGE™ Multi for Dogs may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer PARASEDGE™ Multi for Dogs immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with PARASEDGE™ Multi for Dogs should be given within one month of the last dose of the former medication. Treatment of Circulating Microfilaria: For the treatment of circulating D. immitis microfilaria in heartworm-positive dogs, PARASEDGE™ Multi for Dogs should be administered at one-month intervals. Treatment with an approved adulticide therapy is recommended because PARASEDGE™ Multi for Dogs is not effective for the treatment of adult D. immitis. (See PRECAUTIONS.) Flea Treatment: For the treatment of flea infestations, PARASEDGE™ Multi for Dogs should be administered at one-month intervals. If the dog is already infested with fleas when the first dose of PARASEDGE™ Multi for Dogs is administered, adult fleas on the dog will be killed. However, reinfestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated. Dogs treated with imidacloprid, including those with pre-existing flea allergy dermatitis have shown clinical improvement as a direct result of elimination of fleas from the dog. Treatment and Control of Intestinal Nematode Infections: For the treatment and control of intestinal hookworm infections caused by Ancylostoma caninum and Uncinaria stenocephala (adults, immature adults and fourth stage larvae) and roundworm infections caused by Toxocara canis (adults and fourth stage larvae), and Toxascaris leonina (adults), and whipworm infections caused by Trichuris vulpis (adults), PARASEDGE™ Multi for Dogs should be administered once as a single topical dose. Treatment and Control of Sarcoptic Mange: For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis, PARASEDGE™ Multi for Dogs should be administered as a single topical dose. A second monthly dose may be administered if necessary.

TOPICAL

PARASEDGE™ Multi for Dogs(imidacloprid + moxidectin) Topical Solution

The recommended minimum dose is 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. As specified in the following table, administer the entire contents of the PARASEDGE™ Multi for Cats (10% imidacloprid + 1% moxidectin) tube that correctly corresponds with the body weight of the cat. Do not get this product in the cat’s mouth or eyes or allow the cat to lick the application site for 30 minutes. Treatment at the base of the head will minimize the opportunity for ingestion by grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff, matted hair or a damp, oily appearance of the hair may be observed at the application site on some cats. This is temporary and does not affect the safety and effectiveness of the product. Heartworm Prevention: For prevention of heartworm disease, PARASEDGE™ Multi for Cats should be administered at one-month intervals. PARASEDGE™ Multi for Cats may be administered year-around or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer PARASEDGE™ Multi for Cats immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with PARASEDGE™ Multi for Cats should be given within one month of the last dose of the former medication. At the discretion of the veterinarian, cats older than 6 months of age may be tested to determine the presence of existing heartworm infection before treatment with PARASEDGE™ Multi for Cats (See ADVERSE REACTIONS Post-Approval Experience). Flea Treatment: For the treatment of flea infestations, PARASEDGE™ Multi for Cats should be administered at one-month intervals. If the cat is already infested with fleas when the first dose of PARASEDGE™ Multi for Cats is administered, adult fleas on the cat will be killed. However, re-infestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated. Cats treated with imidacloprid, including those with pre-existing flea allergy dermatitis have shown clinical improvement as a direct result of elimination of fleas from the cat. Ear Mite Treatment: For the treatment of ear mites (Otodectes cynotis), PARASEDGE™ Multi for Cats should be administered once as a single topical dose. Monthly use of PARASEDGE™ Multi for Cats will control any subsequent ear mite infestations. Intestinal Nematode Treatment: For the treatment and control of intestinal hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults and fourth stage larvae) and roundworm infections caused by Toxocara cati (adults and fourth stage larvae), PARASEDGE™ Multi for Cats should be administered once as a single topical dose.

TOPICAL

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

Credelio Quattro/Credelio Quattro-CA1 is given orally at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt). Credelio Quattro/Credelio Quattro-CA1 must be administered with food (see Clinical Pharmacology ). Care should be taken to ensure that the dog consumes the complete dose and that part of the dose is not lost or refused. If vomiting occurs within an hour after administration, readminister a new dose of Credelio Quattro/Credelio Quattro-CA1. Credelio Quattro: Credelio Quattro is given once a month. If a dose is missed, give Credelio Quattro immediately and resume a monthly dosing schedule. Dosing Schedule: *As pamoate salt Body Weight (lbs) Tablets to Administer Lotilaner per Tablet (mg) Moxidectin per Tablet (mg) Praziquantel per Tablet (mg) Pyrantel* per Tablet (mg) 3.3 – 6 1 56.25 0.056 14.25 14.25 6.1 – 12 1 112.5 0.113 28.5 28.5 12.1 – 25 1 225 0.225 57 57 25.1 – 50 1 450 0.45 114 114 50.1 – 100 1 900 0.9 228 228 > 100 Administer the appropriate combination of tablets Heartworm Prevention Credelio Quattro should be administered year-round at monthly intervals or at least within 1 month of the animal’s first seasonal exposure to mosquitoes and continuing until at least 1 month after the dog’s last seasonal exposure. If a dose is missed, give Credelio Quattro immediately and resume monthly dosing. When replacing a monthly heartworm preventive product, Credelio Quattro should be given within 1 month of the last dose of the former medication. Intestinal Nematode and Cestode Treatment and Control Credelio Quattro should be administered as a single dose for the treatment of roundworm, hookworm, and tapeworm infections. Monthly use of Credelio Quattro will control any subsequent infections. Dogs may be exposed to and can become infected with gastrointestinal worms throughout the year, regardless of season or climate. Clients should be advised of appropriate measures to prevent reinfection of their dog with intestinal parasites. Flea Treatment and Prevention Treatment with Credelio Quattro should be administered year-round at monthly intervals or started at least 1 month before fleas become active. To minimize the likelihood of flea re-infestation, it is important to treat all dogs and cats within a household with a flea control product. Tick Treatment and Control Treatment with Credelio Quattro can begin at any time of the year. Credelio Quattro should be administered year-round at monthly intervals or started at least 1 month before ticks become active. Credelio Quattro-CA1: New World Screwworm (NWS) Myiasis Treatment A single dose of Credelio Quattro-CA1 is reasonably expected to treat C. hominivorax present at the time of treatment. Re-infestation with C. hominivorax may occur sooner than one month. Treatment should be used in conjunction with the mechanical removal of larvae (live and dead) remaining in the wound after treatment (see PRECAUTIONS ).

ORAL

Credelio Quattro™ CredelioQuattro™-CA1(lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets)

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1.Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the Advantage Multi for Dogs tube that correctly corresponds with the body weight of the dog. * Dogs over 110 lbs. should be treated with the appropriate combination of Advantage Multi for Dogs tubes. Dog (lbs.) Advantage Multi For Dogs Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 Advantage Multi 9 0.4 40 10 9.1–20 Advantage Multi 20 1.0 100 25 20.1–55 Advantage Multi 55 2.5 250 62.5 55.1–88 Advantage Multi 88 4.0 400 100 88.1–110* Advantage Multi 110 5.0 500 125 2.While holding the tube in an upright position, remove the cap from the tube. 3.Turn the cap over and push the other end of cap onto the tip of the tube. 4.Twist the cap to break the seal and then remove cap from the tube. 5.The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.) Contact with eyes can lead to eye irritation and corneal ulceration. If contact with eyes occurs, hold the dog’s eyelids open, flush thoroughly with water, and contact your veterinarian. Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of Advantage Multi for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Advantage Multi for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.

TOPICAL

Elanco TM advantage multi™ for dogs (imidacloprid+moxidectin) Topical Solution

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. Remove the applicator from the outer pouch using scissors or fold along diagonal line to expose nick; tear back at nick. As specified in the following table, administer the entire contents of the Midamox for Dogs (imidacloprid and moxidectin) applicator that correctly corresponds with the body weight of the dog. * Dogs over 110 lbs. should be treated with the appropriate combination of Midamox for Dogs applicators. Dog (lbs.) Midamox for Dogs Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 Midamox 9 0.4 40 10 9.1–20 Midamox 20 1.0 100 25 20.1–55 Midamox 55 2.5 250 62.5 55.1–88 Midamox 88 4.0 400 100 88.1–110* Midamox 110 5.0 500 125 Hold the applicator upright. Tap the narrow part of the applicator to ensure the contents remain within the main body of the applicator. Twist or snap back the tip. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the applicator on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the applicator on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.) Contact with eyes can lead to eye irritation and corneal ulceration. If contact with eyes occurs, hold the dog's eyelids open, flush thoroughly with water, and contact your veterinarian. Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of Midamox for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Midamox for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.

TOPICAL

VETone ® Midamox ® for Dogs (imidacloprid + moxidectin)

SIMPARICA TRIO is given orally once a month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) sarolaner, 0.011 mg/lb (24 μg/kg) moxidectin, and 2.27 mg/lb (5 mg/kg) pyrantel (as pamoate salt). Dosage Schedule Body Weight (lbs) Sarolaner per Tablet (mg) Moxidectin per Tablet (mg) Pyrantel per Tablet (mg) Number of Tablets Administered 2.8 to 5.5 3 0.06 12.5 One 5.6 to 11.0 6 0.12 25 One 11.1 to 22.0 12 0.24 50 One 22.1 to 44.0 24 0.48 100 One 44.1 to 88.0 48 0.96 200 One 88.1 to 132.0 72 1.44 300 One >132.0 Administer the appropriate combination of tablets SIMPARICA TRIO can be offered to the dog with or without food. Care should be taken to ensure that the dog consumes the complete dose and that part of the dose is not lost or refused. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing. Heartworm Prevention: SIMPARICA TRIO should be administered at monthly intervals year‑round or at least within one month of the animal’s first seasonal exposure to mosquitoes and continuing until at least 1 month after the dog’s last seasonal exposure. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing. When replacing a monthly heartworm preventive product, SIMPARICA TRIO should be given within one month of the last dose of the former medication. Flea Treatment and Prevention: Treatment with SIMPARICA TRIO may begin at any time of the year. SIMPARICA TRIO should be administered year‑round at monthly intervals or started at least one month before fleas become active. To minimize the likelihood of flea re‑infestation, it is important to treat all dogs and cats within a household with a flea control product. Tapeworm Prevention: Treatment with SIMPARICA TRIO may begin at any time of the year. SIMPARICA TRIO should be administered year-round at monthly intervals or started at least one month before fleas become active. SIMPARICA TRIO will only prevent D. caninum infections by killing the fleas on the treated dog. Dogs may also become infected with D. caninum by ingesting fleas from untreated animals, it is therefore recommended that all pets in a household are treated for fleas. Tick Treatment and Control: Treatment with SIMPARICA TRIO can begin at any time of the year. SIMPARICA TRIO should be administered year‑round at monthly intervals or started at least one month before ticks become active. Intestinal Nematode Treatment and Control: For the treatment of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections, SIMPARICA TRIO should be administered once as a single dose. Monthly use of SIMPARICA TRIO will control any subsequent infections.

ORAL

Simparica TRIO®

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1. Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the IMOXI™ Topical Solution for Dogs tube that correctly corresponds with the body weight of the dog. Dog (lbs.) Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 0.4 40 10 9.1–20 1.0 100 25 20.1–55 2.5 250 62.5 55.1–88 4.0 400 100 88.1–110 Dogs over 110 lbs. should be treated with the appropriate combination of IMOXI™ Topical Solution for Dogs tubes. 5.0 500 125 2. While holding the Twist•N•Go™ tube in an upright position, twist the dispensing cap clockwise about ½ turn to break the tube's seal. Remove the cap from the tube. 3. The dog should be standing for application. Position the dispensing tip on the dog's back between the shoulder blades. The dispensing tip of the tube can be used to part the dog's hair until the skin is visible. 4. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS) Contact with eyes can lead to eye irritation and corneal ulceration. If contact with eyes occurs, hold the dog's eyelids open, flush thoroughly with water, and contact your veterinarian. Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of IMOXI™ Topical Solution for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of IMOXI™ Topical Solution for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.

TOPICAL

IMOXI™ Topical Solution for Dogs (imidacloprid + moxidectin)

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the Barrier for Dogs (imidacloprid + moxidectin) tube that correctly corresponds with the body weight of the dog. * Dogs over 110 lbs. should be treated with the appropriate combination of Barrier for Dogs tubes. Dog (lbs.) Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 0.4 40 10 9.1–20 1.0 100 25 20.1–55 2.5 250 62.5 55.1–88 4.0 400 100 88.1–110* 5.0 500 125 While holding the tube in an upright position, twist the cap to break the seal and apply. The cap will remain on the tube. 3. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS.) Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of Barrier for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Barrier for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas.

TOPICAL

Barrier® for Dogs(imidacloprid+moxidectin)Topical Solution

Bravecto Plus should be administered topically as a single dose every 2 months according to the Dosage Schedule below to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. For prevention of heartworm disease, Bravecto Plus should be administered at 2-month intervals. Bravecto Plus may be administered year-round without interruption or at a minimum should be administered at 2-month intervals beginning at the cat's first seasonal exposure to mosquitoes and continuing until the cat's last seasonal exposure to mosquitoes. If a dose is missed and a 2-month interval between doses is exceeded, administer Bravecto Plus immediately and resume the dosing every 2 months. When replacing a monthly heartworm preventative product, the first dose of Bravecto Plus should be given within one month of the last dose of the former medication. Dosing Schedule: Body Weight Ranges (lb) Fluralaner content (mg/tube) Moxidectin content (mg/tube) Tubes Administered 2.6 – 6.2 112.5 5.6 One >6.2 – 13.8 250 12.5 One >13.8 – 27.5Cats over 27.5 lb should be administered the appropriate combination of tubes. 500 25 One A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying Bravecto Plus topically to cats prior to first use. Step 1: Immediately before use, open the pouch and remove the tube. Put on gloves. Hold the tube at the crimped end with the cap in an upright position (tip up). The cap should be rotated clockwise or counter clockwise one full turn. The cap is designed to stay on the tube for dosing and should not be removed. The tube is open and ready for application when a breaking of the seal is felt. Step 2: The cat should be standing or lying with its back horizontal during application. Part the fur at the administration site. Place the tube tip vertically against the skin at the base of the skull of the cat. Step 3: Squeeze the tube and gently apply the entire contents of Bravecto Plus directly to the skin at the base of the skull of the cat. Avoid applying an excessive amount of solution that could cause some of the solution to run and drip off of the cat. If a second spot is needed to avoid run off, then apply the second spot slightly behind the first spot. Greasy, oily, or wet appearance may occur at the application site in some cats.

TOPICAL

BRAVECTO® PLUS (fluralaner and moxidectin topical solution) for Cats

Dosage: MoxiSolv Pour-On (moxidectin) is a ready-to-use topical formulation intended for direct application to the hair and skin in a narrow strip extending along the top of the back from the withers to the tailhead (see Figure 1). Due to the angular topline characteristic of most dairy breeds, it is recommended that all pour on products be applied slowly to dairy cows. Apply to healthy skin avoiding any mange scabs, skin lesions, mud or manure. Treated cattle can be easily recognized by the characteristic purple color, which will remain for a short period of time after treatment. The recommended rate of administration is 1 mL for each 22 lb (10 kg) body weight which provides 0.5 mg moxidectin for each 2.2 lb (0.5 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of pour-on which must be applied based on the weight of animal being treated. Figure 1. Where to Apply MoxiSolv Pour-On Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance. Use Conditions: Varying weather conditions, including rainfall, do not affect the efficacy of MoxiSolv Pour-On. Administration: MoxiSolv Pour-On is available in two convenient package styles designed for ease of administration and the number of cattle to be treated. Directions for use of each container type follow: Large Conventional Containers (169 fl oz/5 L Bottles and 338 fl oz/10 L Cubetainer) These bottles are designed for use with most commercially-available applicators. Simply remove the transient cap and seal and replace with the vented cap. Attach the applicator feeder hose to the vented cap. Invert the container prior to use (5 L containers only). Apply the recommended volume of MoxiSolv Pour-On evenly along the backline of the animal from the withers to the tailhead (see Figure 1).

TOPICAL

FDA application 200-845

The recommended minimum dose is 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1. Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the Barrier for Cats tube that correctly corresponds with the body weight of the cat. * Cats over 18 lbs. should be treated with the appropriate combination of Barrier for Cats tubes. Cat (lbs.) Volume (mL) Imidacloprid (mg) Moxidectin (mg) 2–5 0.23 23 2.3 5.1–9 0.4 40 4 9.1–18* 0.8 80 8 2. While holding the tube in an upright position, twist the cap to break the seal and then apply. The cap will remain on the tube.3.Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible. Place the tip of the tube on the skin and apply the entire contents directly on the exposed skin. Lift tube away from skin before releasing pressure on tube. 3. Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible. Place the tip of the tube on the skin and apply the entire contents directly on the exposed skin. Lift tube away from skin before releasing pressure on tube. Do not get this product in the cat's mouth or eyes or allow the cat to lick the application site for 30 minutes. Treatment at the base of the head will minimize the opportunity for ingestion by grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff, matted hair or a damp, oily appearance of the hair may be observed at the application site on some cats. This is temporary and does not affect the safety and effectiveness of the product.

TOPICAL

Barrier® for Cats (imidacloprid+moxidectin) Topical Solution

The recommended minimum dose is 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1. Remove the applicator from the outer pouch using scissors or fold along diagonal line to expose nick; tear back at nick. As specified in the following table, administer the entire contents of the Midamox for Cats (imidacloprid and moxidectin) applicator that correctly corresponds with the body weight of the cat. * Cats over 18 lbs. should be treated with the appropriate combination of Midamox for Cats applicators. Cat (lbs.) Midamox for Cats Volume (mL) Imidacloprid (mg) Moxidectin (mg) 2–5 Midamox 5 0.23 23 2.3 5.1–9 Midamox 9 0.4 40 4 9.1–18* Midamox 18 0.8 80 8 Hold the applicator upright. Tap the narrow part of the applicator to ensure the contents remain within the main body of the applicator. Twist or snap back the tip. Part the hair on the back of the cat's neck at the base of the head in front of the shoulder blades, until the skin is visible. Place the tip of the applicator on the skin and squeeze the applicator several times to empty its contents completely and directly onto the skin in one spot. Do not get this product in the cat's mouth or eyes or allow the cat to lick the application site for 30 minutes. Treatment at the base of the head will minimize the opportunity for ingestion by grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff, matted hair or a damp, oily appearance of the hair may be observed at the application site on some cats. This is temporary and does not affect the safety and effectiveness of the product.

TOPICAL

VETone®Midamox ® for Cats (imidacloprid + moxidectin)

The recommended minimum dose is 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1.Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the Advantage Multi for Cats tube that correctly corresponds with the body weight of the cat. * Cats over 18 lbs. should be treated with the appropriate combination of Advantage Multi for Cats tubes. Cat (lbs.) Advantage Multi For Cats Volume (mL) Imidacloprid (mg) Moxidectin (mg) 2–5 Advantage Multi 5 0.23 23 2.3 5.1–9 Advantage Multi 9 0.4 40 4 9.1–18* Advantage Multi 18 0.8 80 8 2.While holding the tube in an upright position, remove the cap from the tube. 3.Turn the cap over and push the other end of cap onto the tip of the tube. 4.Twist the cap to break the seal and then remove cap from the tube. 5.Part the hair on the back of the cat's neck at the base of the head, until the skin is visible. Place the tip of the tube on the skin and apply the entire contents directly on the exposed skin. Lift tube away from skin before releasing pressure on tube. Do not get this product in the cat's mouth or eyes or allow the cat to lick the application site for 30 minutes. Treatment at the base of the head will minimize the opportunity for ingestion by grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff, matted hair or a damp, oily appearance of the hair may be observed at the application site on some cats. This is temporary and does not affect the safety and effectiveness of the product.

TOPICAL

Elanco TM advantage multi™ for cats (imidacloprid+moxidectin) Topical Solution

DOSAGE AND ADMINISTRATION: The recommended minimum dose is 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1. Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the IMOXI™ Topical Solution for Cats tube that correctly corresponds with the body weight of the cat. Cat (lbs.) Volume (mL) Imidacloprid (mg) Moxidectin (mg) 2-5 0.23 23 2.3 5.1-9 0.4 40 4 9.1-18Cats over 18 lbs. should be treated with the appropriate combination of IMOXI™ Topical Solution for Cats tubes. 0.8 80 8 2. While holding the Twist•N•Go™ tube in an upright position, twist dispensing tip clockwise about ½ turn to break the tube's seal. Remove the cap from the tube. 3. Part the hair on the back of the cat's neck at the base of the head, until the skin is visible. 4. Place the tip of the tube on the skin and apply the entire contents directly on the exposed skin. Lift the tube away from the skin before releasing pressure on the tube. Do not get this product in the cat's mouth or eyes or allow the cat to lick the application site for 30 minutes. Treatment at the base of the head will minimize the opportunity for ingestion by grooming. In households with multiple pets, keep animals separated to prevent licking of the application site. Stiff, matted hair or a damp, oily appearance of the hair may be observed at the application site on some cats. This is temporary and does not affect the safety and effectiveness of the product.

TOPICAL

IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin)

DOSAGE The recommended rate of administration for MoxiSolv Injection is 1 mL for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of injectable which must be administered based on the weight of animal being treated. Be careful not to overdose animals; estimate animal's body weight as closely as possible or weigh animals individually. Weight (lb) 165 220 330 440 550 660 770 880 990 1100 Weight (kg) 75 100 150 200 250 300 350 400 450 500 Dose (mL) 1.5 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance. ADMINISTRATION MoxiSolv Injection should be administered by subcutaneous injection under the loose skin in front of or behind the shoulder (Figure 1). Needles 1/2 to 3/4 inch in length and 16 to 18 gauge are recommended for subcutaneous injections. Use sterile, dry equipment and aseptic procedures when withdrawing and administering MoxiSolv. Figure 1. Sites for administration of MoxiSolv Injection

SUBCUTANEOUS

FDA application 200-788

The recommended rate of administration for CYDECTIN Injectable is 1 mL for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of injectable which must be administered based on the weight of animal being treated. Be careful not to overdose animals; estimate animal’s body weight as closely as possible or weigh animals individually. Weight (lb) 165 220 330 440 550 660 770 880 990 1100 Weight (kg) 75 100 150 200 250 300 350 400 450 500 Dose (mL) 1.5 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 •Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance. ADMINISTRATION CYDECTIN Injectable should be administered by subcutaneous injection under the loose skin in front of or behind the shoulder (Figure 1). Needles 1/2 to 3/4 inch in length and 16 to 18 gauge are recommended for subcutaneous injections. Use sterile, dry equipment and aseptic procedures when withdrawing and administering CYDECTIN. Figure 1. Sites for administration of CYDECTIN Injectable

SUBCUTANEOUS

FDA application 141-220

For ferrets: The recommended minimum dose for a ferret is 9 mg/lb (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month, by topical administration. Heartworm Prevention: For prevention of heartworm disease, PARASEDGE Multi for Cats should be administered at one-month intervals. PARASEDGE Multi for Cats may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer PARASEDGE Multi for Cats immediately and resume the monthly dosing schedule. Flea Treatment: For the treatment of flea infestations on ferrets, PARASEDGE Multi for Cats should be administered at one-month intervals. If the ferret is already infested with fleas when the first dose of PARASEDGE Multi for Cats is administered, adult fleas on the ferret will be killed. However, re-infestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated.

TOPICAL

PARASEDGE™ Multi for Cats(imidacloprid + moxidectin)Topical Solution

The recommended rate of administration for Durvet Moxidectin Oral Sheep Drench is 1 mL per 11 lb (5 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of drench in 1.0 mL increments and it must be administered based on the weight of animal being treated. Body Weight Dose Body Weight Dose Body Weight Dose 11 lb 5 kg 1 mL 66 lb 30 kg 6 mL 121 lb 55 kg 11 mL 22 lb 10 kg 2 mL 77 lb 35 kg 7 mL 132 lb 60 kg 12 mL 33 lb 15 kg 3 mL 88 lb 40 kg 8 mL 143 lb 65 kg 13 mL 44 lb 20 kg 4 mL 99 lb 45 kg 9 mL 154 lb 70 kg 14 mL 55 lb 25 kg 5 mL 110 lb 50 kg 10 mL 165 lb 75 kg 15 mL Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

ORAL

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

The recommended rate of administration for Tauramox™ Injectable is 1 mL for each 110 lb (50 kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of injectable which must be administered based on the weight of animal being treated. Be careful not to overdose animals; estimate animal's body weight as closely as possible or weigh animals individually. Weight (lb) 165 220 330 440 550 660 770 880 990 1100 Weight (kg) 75 100 150 200 250 300 350 400 450 500 Dose (mL) 1.5 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

SUBCUTANEOUS

Tauramox™(moxidectin)Injectable Solution for Beefand Nonlactating Dairy Cattle

QUEST PLUS Gel is specially formulated as a palatable gel which is easily administered to horses and ponies. QUEST PLUS Gel is packaged in ready-to-use SURE-DIAL® syringes. The syringe is calibrated in 50-pound increments, up to 1500 pounds. This enables the administration of the recommended dose level by choosing a setting consistent with the animal’s weight. Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineff ective treatment, and encourage the development of parasite resistance.

ORAL

QUEST® PLUS GEL (moxidectin/praziquantel)

QUEST (moxidectin) 2% Equine Oral Gel is specially formulated as a palatable gel which is easily administered to horses and ponies. QUEST Gel is packaged in ready-to-use SURE-DIAL® syringes. The syringe is calibrated in 50-pound increments, up to 1500 pounds. This enables the administration of the recommended dose level of 0.4 mg moxidectin/kg body weight by choosing a setting consistent with the animal’s weight.

ORAL

QUEST® GEL (moxidectin)

Always provide Client Information Sheet and review with owners before administering ProHeart 12. The owner should be advised to observe their dog for adverse drug events including those described on the sheet. The Client Information Sheet is attached to this package insert and available online at http://www.proheart12.com for reprinting to provide to the owner.

SUBCUTANEOUS

ProHeart® 12 (moxidectin)For Extended-Release Injectable Suspension for Dogs

Durvet Moxidectin Oral Sheep Drench is ready-to-use. Administer 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of the sheep, using any standard drenching equipment. Check dose rates and equipment before drenching. Do not overdose. Do not mix with any other products before administration. Avoid contaminating the drench solution.

ORAL

Moxidectin ORAL SHEEP DRENCH™ (moxidectin)

NexGard® PLUS is given orally once a month at the minimum dosage of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes (see Effectiveness).

ORAL

NexGard® PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets)

Always provide Client Information Sheet and review with owners before administering ProHeart 6. The owner should be advised to observe their dog for adverse drug events including those described on the sheet.

SUBCUTANEOUS

ProHeart® 6 (moxidectin)For Extended-Release Injectable Suspension for Dogs

CYDECTIN Pour-On is available in three convenient package styles designed for ease of administration and the number of cattle to be treated. Directions for use of each container type follow:

TOPICAL

FDA application 141-099