Label: NAFTIN- naftifine hydrochloride gel

  • NDC Code(s): 54766-770-40, 54766-770-60, 54766-770-90
  • Packager: Sebela Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 14, 2018

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

  • SPL UNCLASSIFIED SECTION

    Rx ONLY

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  • DESCRIPTION

    Naftin ® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin ® Gel, 1% is for topical use only.

    CHEMICAL NAME

    (E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C 21H 21N•HCl and a molecular weight of 323.86.

    Chemical Structure

    Contains

    Active Ingredient

    Naftifine hydrochloride 1%.

    Inactive Ingredients

    Naftin ® Gel, 1% contains polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium, alcohol (52%v/v), and purified water.

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  • 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 ® Gel, 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 single topical applications of 3H- labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

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  • INDICATIONS AND USAGE

    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 * 1, Epidermophyton floccosum * 1.


    1
    Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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  • CONTRAINDICATIONS

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

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  • WARNINGS

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

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  • PRECAUTIONS

    General

    Naftin ® Gel, 1%, is for external use only. If irritation or sensitivity develops with the use of Naftin ® Gel, 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 Naftin ® Gel, 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, 20, 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/m 2 comparison).

    Pregnancy

    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 Naftin ® Gel,1 % is administered to a nursing woman.

    Pediatric use

    Safety and effectiveness in pediatric patients have not been established.

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  • ADVERSE REACTIONS

    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%).

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  • DOSAGE AND ADMINISTRATION

    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.

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  • HOW SUPPLIED

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

    • 40g – NDC 54766-770-40
    • 60g – NDC 54766-770-60
    • 90g – NDC 54766-770-90

    Note: Store Naftin ® Gel, 1% at room temperature.

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  • SPL UNCLASSIFIED SECTION

    Distributed by Sebela Pharmaceuticals Inc.

    645 Hembree Parkway, Suite I

    Roswell, Georgia 30076

    www.sebelapharma.com

    Toll Free 1-844-732-3521


    © 2018 Sebela Pharmaceuticals Inc. All rights reserved.

    Naftin is a registered trademark of Sebela International Limited.

    Rev. May 2018

    PI 77040001

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  • PRINCIPAL DISPLAY PANEL - 90g Tube Carton

    PRINCIPAL DISPLAY PANEL - Naftin ® Gel 1% 90gNDC 54766-770-90

    NAFTIN ®

    90g gel

    NAFTIFINE HCl 1% GEL

    Rx Only

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  • INGREDIENTS AND APPEARANCE
    NAFTIN 
    naftifine hydrochloride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54766-770
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAFTIFINE HYDROCHLORIDE (UNII: 25UR9N9041) (NAFTIFINE - UNII:4FB1TON47A) NAFTIFINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54766-770-40 1 in 1 CARTON 01/22/2018
    1 40 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:54766-770-60 1 in 1 CARTON 01/22/2018
    2 60 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:54766-770-90 1 in 1 CARTON 01/22/2018
    3 90 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019356 01/22/2018
    Labeler - Sebela Pharmaceuticals Inc. (079104574)
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Ltd. 832224526 manufacture(54766-770) , analysis(54766-770) , pack(54766-770)
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