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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 524.2350: Tolnaftate cream.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  4. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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