• NDC Code(s): 51672-1362-1, 51672-1362-2, 51672-1362-3, 51672-1362-8
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 25, 2018

If you are a consumer or patient please visit this version.


    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.


    (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

    Chemical Structure

    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.


    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.


    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.


    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.



    Naftifine Hydrochloride Cream USP, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream USP, 1%, treatment should be discontinued and appropriate therapy instituted.

    Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

    Information for patients

    The patient should be told to:

    1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
    2. Keep Naftifine Hydrochloride Cream USP, 1% away from the eyes, nose, mouth and other mucous membranes.

    Carcinogenesis, mutagenesis, impairment of fertility

    In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague-Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day [3.6 times the maximum recommended human dose (MRHD) based on mg/m2 comparison].

    Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

    Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m2 comparison).


    Teratogenic Effects

    Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Nursing mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream USP, 1% is administered to a nursing woman.

    Pediatric use

    Safety and effectiveness in pediatric patients have not been established.


    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)

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


    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

  • PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

    NDC 51672-1362-8

    90 g

    Naftifine Hydrochloride
    Cream USP, 1%


    Rx only


    Keep this and all medications out of the reach of children.

    Principal Display Panel - 90 g Tube Carton
    naftifine hydrochloride cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51672-1362
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naftifine Hydrochloride (UNII: 25UR9N9041) (Naftifine - UNII:4FB1TON47A) Naftifine Hydrochloride10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetyl esters wax (UNII: D072FFP9GU)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    hydrochloric acid (UNII: QTT17582CB)  
    Product Characteristics
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-1362-11 in 1 CARTON09/08/2016
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-1362-21 in 1 CARTON09/08/2016
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51672-1362-31 in 1 CARTON09/08/2016
    360 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51672-1362-81 in 1 CARTON09/08/2016
    490 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-1362)