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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.450]



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

Sec. 524.450 Clotrimazole.

(a) Specifications. Each gram of cream contains 10 milligrams of clotrimazole.

(b) Sponsors. See No. 000859 in 510.600(c) of this chapter.

(c) Conditions of use --(1) Amount. Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.

(2) Indications of use. For the treatment of fungal infections of dogs and cats caused by Microsporum canis and Trichophyton mentagrophytes.

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

[40 FR 48128, July 18, 1980, as amended at 79 FR 10967, Feb. 27, 2014]

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