diclofenac

For the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock, and pastern) joints in horses.

Do not use in horses intended for human consumption.

Surpass® Topical Anti-Inflammatory Cream

SURPASS topical cream is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses.

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties. The mechanism of action of diclofenac, like other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity.

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses

SURPASS topical cream is contraindicated in animals with known hypersensitivity to diclofenac.

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses

Do not use in horses intended for human consumption. User Safety: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. Wear gloves to prevent absorption into the hands. Direct contact with the skin should be avoided. If contact occurs, the skin should be washed immediately with soap and water. Animal Safety: For topical use in horses only. Owners should be advised to observe for signs of potential drug toxicity (see Information for Owner or Person Treating Animal and Adverse Reactions).

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses

During the field study, one diclofenac-treated horse developed colic on day four of the study and responded to symptomatic treatment. One placebo-treated horse exhibited mildly jaundiced mucous membranes on day five. Adverse reactions during the safety study included a gastric ulcer in one horse that received 5.6X the recommended dosage, diarrhea and uterine discharge in one horse that received 2.8X the recommended dosage, and weight loss in four of the six horses in the 5.6X dosage group. To report suspected adverse reactions, to obtain a Safety Data Sheet or for technical assistance, call 1-888-637-4251. 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.

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses

Apply a 5-inch (5'') ribbon of cream twice daily over the affected joint for up to 10 days and rub thoroughly into the hair covering the joint until it disappears.

Topical

Do not use in horses intended for human consumption.

Surpass® Topical Anti-Inflammatory Cream

Always provide the Client Information Sheet with the prescription. Dosage: Apply a five-inch (5") ribbon of SURPASS topical cream twice daily over the affected joint for up to ten days. Administration: Wear rubber gloves to prevent absorption into the hands. Rub the cream thoroughly into the hair covering the joint until it disappears.

TOPICAL

Surpass® (1% diclofenac sodium) Topical Anti-Inflammatory Cream For Use in Horses