21 CFR § 524.1443 - Miconazole.

---
identifier: "/us/cfr/t21/s524.1443"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1443 - Miconazole."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1443"
section_name: "Miconazole."
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"
---


# 524.1443 Miconazole.

(a) *Specifications.* (1) Each gram of cream contains miconazole nitrate equivalent to 20 milligrams miconazole base.

(2) Each gram of lotion or spray contains miconazole nitrate equivalent to 1 percent miconazole base.

(b) *Sponsors.* See § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 000061 for use of cream, lotion, and spray;

(2) Nos. 054925 and 058829 for use of lotion and spray.

(c) *Conditions of use in dogs and cats*—(1) *Amount.* Apply once daily by rubbing into or spraying a light covering on the infected site and the immediate surrounding vicinity. Continue treatment for 2 to 4 weeks until infection is completely eradicated as determined by appropriate laboratory examination.

(2) *Indications for use.* For topical treatment of infections caused by *Microsporum canis*, *Microsporum gypseum*, and *Trichophyton mentagrophytes.*

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

[71 FR 13542, Mar. 16, 2006]