Naftifine Hydrochloride NAFTIFINE HYDROCHLORIDE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved Naftifine Hydrochloride Cream USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream USP, 1% is for topical use only. 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. Structural Formula naftifine hydrochloride Contains Active Ingredient Naftifine hydrochloride 1% Inactive Ingredients benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH. Chemical Structure

Drug Facts

Composition & Profile

Strengths
1 % 15 g 30 g 60 g 90 g
Quantities
8 count
Treats Conditions
Indications And Usage Naftifine Hydrochloride Cream Usp 1 Is Indicated For The Topical Treatment Of Tinea Pedis Tinea Cruris And Tinea Corporis Caused By The Organisms Trichophyton Rubrum Trichophyton Mentagrophytes And Epidermophyton Floccosum
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
UNII
25UR9N9041
Packaging

HOW SUPPLIED Naftifine Hydrochloride Cream USP, 1% is supplied in the following sizes: 15 g - NDC 51672-1362-1 (tube) 30 g - NDC 51672-1362-2 (tube) 60 g - NDC 51672-1362-3 (tube) 90 g - NDC 51672-1362-8 (tube) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-1362-8 90 g Naftifine Hydrochloride Cream USP, 1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only TARO Keep this and all medications out of the reach of children. Principal Display Panel - 90 g Tube Carton

Package Descriptions
  • HOW SUPPLIED Naftifine Hydrochloride Cream USP, 1% is supplied in the following sizes: 15 g - NDC 51672-1362-1 (tube) 30 g - NDC 51672-1362-2 (tube) 60 g - NDC 51672-1362-3 (tube) 90 g - NDC 51672-1362-8 (tube) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-1362-8 90 g Naftifine Hydrochloride Cream USP, 1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only TARO Keep this and all medications out of the reach of children. Principal Display Panel - 90 g Tube Carton

Overview

Naftifine Hydrochloride Cream USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream USP, 1% is for topical use only. 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. Structural Formula naftifine hydrochloride Contains Active Ingredient Naftifine hydrochloride 1% Inactive Ingredients benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH. Chemical Structure

Indications & Usage

Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .

Dosage & Administration

A sufficient quantity of Naftifine Hydrochloride Cream USP, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream USP, 1%, the patient should be re-evaluated.

Warnings & Precautions
WARNINGS Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.
Contraindications

Naftifine Hydrochloride Cream USP, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Adverse Reactions

During clinical trials with Naftifine Hydrochloride Cream USP, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).

Storage & Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →