CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1443]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 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]