21 CFR § 524.1443 - Miconazole.

§ 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]