Drug Catalog - Product Detail
NAFTIFINE HYDROCHLORIDE 1.00% GEL 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00115-1510-58 | AMNEAL PHARMACEUTICALS | 60 | 1% | GEL |
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Description
DESCRIPTION Naftifine Hydrochloride Gel USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Gel USP, 1% is for topical use only. Naftifine Hydrochloride Chemical Structure Chemical Name (E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C 21 H 21 N•HCl and a molecular weight of 323.86. Contains Active Ingredient Naftifine hydrochloride…. 1% Inactive Ingredients Alcohol (52%v/v), carbopol 974P, diisopropanolamine, edetate disodium, polysorbate 80 and purified water. Naftifine Hydrochloride Chemical Structure
How Supplied
HOW SUPPLIED Naftifine Hydrochloride Gel USP, 1% is supplied in collapsible tubes in the following sizes: 40g – NDC 0115-1510-63 60g – NDC 0115-1510-58 90g – NDC 0115-1510-48 Note: Store 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]. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006119 Rev. 0 11/18
Indications & Usage
INDICATIONS AND USAGE Naftifine Hydrochloride Gel USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans 1 and Epidermophyton floccosum. 1 1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Dosage and Administration
DOSAGE AND ADMINISTRATION A sufficient quantity of Naftifine Hydrochloride Gel USP, 1% should be gently massaged into the affected and surrounding skin areas twice a day, in the morning and evening. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Gel USP, 1% the patient should be re-evaluated.