21 CFR § 524.450 - Clotrimazole.

---
identifier: "/us/cfr/t21/s524.450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.450 - Clotrimazole."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.450"
section_name: "Clotrimazole."
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"
---


# 524.450 Clotrimazole.

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

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Apply 
1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.

(2) *Indications of use.* For the treatment of fungal infections of dogs and cats caused by *Microsporum canis* and *Trichophyton mentagrophytes.*

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 48128, July 18, 1980, as amended at 79 FR 10967, Feb. 27, 2014; 86 FR 14820, Mar. 19, 2021]