21 C.F.R. § 524.1443

Miconazole.

Last amended: 2026Year: 2026Length: 169 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 524.1443 (2026)

(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) 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. [71 FR 13542, Mar. 16, 2006, as amended at 91 FR 41560, July 7, 2026]
Cross-references to the CFR
510.600
21 C.F.R. § 524.1443: Miconazole. | Justis AI