Drug Catalog - Product Detail
NAFTIFINE HCL CREAM 2% 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-1512-58 | AMNEAL PHARMACEUTICALS | 60 | 2% | CREAM |
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Description
11 DESCRIPTION Naftifine Hydrochloride Cream USP, 2% is a white to off-white cream for topical use only. Each gram of Naftifine Hydrochloride Cream USP, 2% contains 20 mg of naftifine hydrochloride (2%), a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21 H 21 N•HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is: Naftifine Hydrochloride Cream USP, 2% contains the following inactive ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, sodium hydroxide, sorbitan monostearate, stearyl alcohol, and purified water. Hydrochloric acid may be added to adjust pH. Chemical structure of Naftifine Hydrochloride.
How Supplied
16 HOW SUPPLIED/STORAGE & HANDLING How Supplied Naftifine Hydrochloride Cream USP, 2% is a white to off-white cream supplied in collapsible tubes in the following sizes: 30g – NDC 0115-1512-45 45g – NDC 0115-1512-46 60g – NDC 0115-1512-58 Storage Store Naftifine Hydrochloride Cream USP, 2% at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Naftifine Hydrochloride Cream, 2% is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum . Naftifine Hydrochloride Cream, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum . ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For topical use only. Naftifine Hydrochloride Cream, 2% is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Hydrochloride Cream, 2% once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks. For topical use only. Naftifine Hydrochloride Cream, 2% is not for ophthalmic, oral, or intravaginal use. ( 2 ) Apply a thin layer of Naftifine Hydrochloride Cream, 2% once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks. ( 2 )