Naftin^®
naftifine HCl 1% Gel

Rx Only

Naftin^® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride.

Naftin^® Gel, 1% is for topical use only.

(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride.

Naftifine hydrochloride has an empirical formula of C21H21N•HCI and a molecular weight of 323.86.

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. Naftin^® Gel, 1% has only been shown to be clinically effective against the disease entities uled 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.

Naftin^® Gel, 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*Efficacy for this organism in this organ system was studied in fewer than 10 infections. and Epidermophyton floccosum.

Naftin^® Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Naftin^® Gel, 1% is for topical use only and not for ophthalmic use.

During clinical trials with Naftin^® Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).

A sufficient quantity of Naftin^® Gel, 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 Naftin^® Gel, 1%, the patient should be re-evaluated.

Naftin^® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes:

20g _ NDC 0259-4770-20
40g _ NDC 0259-4770-40
60g _ NDC 0259-4770-60

Note: Store at room temperature.

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410

© 2004 Merz Pharmaceuticals
Rev 4/04 Printed in U.S.A.

30-1365-00
128022-0404