Label: NAFTIFINE HYDROCHLORIDE cream

Rx ONLY

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 C21H21N∙HCl and a molecular weight of 323.86.

Structural Formula

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.

Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans. Naftifine Hydrochloride Cream USP, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section.

Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

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.

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

Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.

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%).

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.

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)

Manufactured by:
Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Distributed by:
Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.

Revised: May 2018
PK-7357-2 10

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.