NAFTIN CREAM 1% - naftifine hydrochloride cream 
DPT Laboratories, Ltd.

----------

Naftin® Cream, 1%

Rx Only

DESCRIPTION

Naftin® Cream, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin® Cream, 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
naftin_structural_formula_01
naftifine hydrochloride

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.

CLINICAL PHARMACOLOGY

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® Cream, 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.

Pharmacokinetics

In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.

Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

INDICATIONS AND USAGE

Naftin® Cream, 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.

CONTRAINDICATIONS

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

WARNINGS

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

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

A sufficient quantity of Naftin® Cream, 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 Naftin® Cream, 1%, the patient should be reevaluated.

HOW SUPPLIED

Naftin® (naftifine hydrochloride) 1% Cream is supplied in the following sizes:









Tubes: Store below 30°C (86°F).
Pumps: Store at controlled room temperature: 25°C (77°F);

excursions permitted between 15°-30°C (59°-86°F).

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410

© 2008 Merz Pharmaceuticals
Rev. 5/08 Printed in U.S.A.

5011316

PRINCIPAL DISPLAY PANEL







Not for Ophthalmic Use
Net Wt. 30 g
Naftin_Crm_Pmp_30_01
Naftin_Crm_Pmp_30_02







Not for Ophthalmic Use
Net Wt. 90 g
Naftin_Crm_Pmp_90_01
Naftin_Crm_Pmp_90_02


NDC 0259-4126-90
90 g Cream








Naftin_Crm_90_01
Naftin_Crm_90_02


NDC 0259-4126-30
30 g Cream








Naftin_Crm_30_01
Naftin_Crm_30_02


NDC 0259-4126-60
60 g Cream








Naftin_Crm_60_01
Naftin_Crm_60_02


Professional Sample
NDC 0259-4126-02
2 g Cream








Naftin_Crm_2_01


NAFTIN  CREAM 1%
naftinine hydrochloride 1% cream   cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63094-4126
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAFTIFINE HYDROCHLORIDE (NAFTIFINE) NAFTIFINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYL ALCOHOL  
ISOPROPYL MYRISTATE  
POLYSORBATE 60  
WATER  
SODIUM HYDROXIDE  
SORBITAN MONOSTEARATE  
STEARYL ALCOHOL  
HYDROCHLORIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 63094-4126-1 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP
1 30 g In 1 BOTTLE, PUMP This package is contained within the CARTON (63094-4126-1)
2 63094-4126-7 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP
2 90 g In 1 BOTTLE, PUMP This package is contained within the CARTON (63094-4126-7)
3 63094-4126-9 1 TUBE In 1 CARTON contains a TUBE
3 90 g In 1 TUBE This package is contained within the CARTON (63094-4126-9)
4 63094-4126-3 1 TUBE In 1 CARTON contains a TUBE
4 30 g In 1 TUBE This package is contained within the CARTON (63094-4126-3)
5 63094-4126-6 1 TUBE In 1 CARTON contains a TUBE
5 60 g In 1 TUBE This package is contained within the CARTON (63094-4126-6)
6 63094-4126-2 2 g In 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019599 01/25/2006

Labeler - DPT Laboratories, Ltd. (621782218)
Registrant - DPT Laboratories, Ltd. (621782218)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 621782218 manufacture
Revised: 08/2009 DPT Laboratories, Ltd.