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524.2350—Tolnaftate cream.

(a) Specifications. The drug contains 1 percent tolnaftate (2-naphthyl-N -methyl-N -(3-tolyl) thionocarbamate) in an anhydrous cream base.

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

(c) Conditions of use. (1) The drug is indicated for treatment of ringworm lesions due to Microsporum canis and Microsporum gypseum in dogs and cats.

(2) A small amount of the cream is applied to the affected areas once or twice a day for 2 to 4 weeks. The areas to be treated are first cleared of exudate and the hair clipped if the areas are not already denuded. The cream is massaged into each lesion and immediate surrounding area until the cream is no longer visible.

(3) If no response is seen after 2 weeks of treatment with the drug the diagnosis should be reviewed.

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

Code of Federal Regulations

[43 FR 29289, July 7, 1978, as amended at 52 FR 7833, Mar. 13, 1987]

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