21 CFR § 524.590 - Diclofenac.

---
identifier: "/us/cfr/t21/s524.590"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.590 - Diclofenac."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.590"
section_name: "Diclofenac."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.590 Diclofenac.

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

(b) *Sponsor.* See No. 000010 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.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 40767, July 7, 2004, as amended at 74 FR 26782, June 4, 2009; 74 FR 47436, Sept. 16, 2009]