CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.2350]

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

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.2350 Tolnaftate cream.

(a) Specifications. The drug contains 1 percent tolnaftate in an anhydrous cream base.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Apply a small amount of the cream to the affected areas once or twice a day for 2 to 4 weeks.

(2) Indications for use. For the treatment of ringworm lesions due to Microsporum canis and Microsporum gypseum.

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

[79 FR 10972, Feb. 27, 2014]