---
kind: "section"
citation: "21 C.F.R. § 524.1443"
title: "21"
number: "524.1443"
heading: "Miconazole."
url: "https://uscodex.org/cfr/21/524.1443"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section:
  - (1) **No.** 000061 for use of cream, lotion, and spray;
  - (2) **No.** 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.

## Notes

### Amendments

[71 FR 13542, Mar. 16, 2006, as amended at 91 FR 41560, July 7, 2026]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.

### Amendments

[71 FR 13542, Mar. 16, 2006, as amended at 91 FR 41560, July 7, 2026]