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Naftifine Cream
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  • FDA PI

Naftifine Cream

Generic name: naftifine hydrochloride
Dosage form: cream
Drug class:Topical antifungals

Medically reviewed by Drugs.com. Last updated on Jan 1, 2021.

Indications and Usage for Naftifine Cream

Naftifine hydrochloride cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum.

Naftifine Cream Dosage and Administration

For topical use only. Naftifine hydrochloride cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of naftifine hydrochloride cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks.

Dosage Forms and Strengths

Each gram contains 20 mg of naftifine hydrochloride (2%) in a white to off-white base.

Contraindications

None

Warnings and Precautions

Local Adverse Reactions

Discontinue treatment if irritation or sensitivity develops with the use of naftifine hydrochloride cream. Direct patients to contact their physician if these conditions develop following use of naftifine hydrochloride cream.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

During clinical trials, 903 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 564 subjects with interdigital tinea pedis, tinea cruris, or tinea corporis were treated with naftifine hydrochloride cream.

In two randomized, vehicle-controlled trials (...