21 C.F.R. § 524.590   Diclofenac.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.590   Diclofenac.

(a) Specifications. Each gram of cream contains 10 milligrams diclofenac sodium.

(b) Sponsor. See No. 065274 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 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.

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

(3) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 40767, July 7, 2004]

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