NAFTIN (NAFTIFINE HYDROCHLORIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]

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NAFTIN (NAFTIFINE HYDROCHLORIDE) CREAM [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-2240-2
Set ID 29c570d7-9483-42dd-a7a4-d466256e8259
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class Allylamine Antifungal
Product Number
Application Number NDA019599
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  • SPL UNCLASSIFIED SECTION

    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.

    Chemical Structure

    Active Ingredient
    Naftifine hydrochloride1%

    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.

  • PRECAUTIONS

    General

    Naftin® Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® Cream, 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® Cream, 1% away from the eyes, nose, mouth and other mucous membranes.

    Carcinogenesis, mutagenesis, impairment of fertility

    Long-term animal studies to evaluate the carcinogenic potential of Naftin® Cream, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category B

    Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more 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® Cream, 1% is administered to a nursing woman.

    Pediatric use

    Safety and effectiveness in pediatric patients have not been established.

  • 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 re-evaluated.

  • HOW SUPPLIED

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

     30g—NDC 54868-2240-2 (tube)

    Tubes:   Store below 30° (86°F).
    Pumps:  Store at controlled room temperature: 25°C (77°F);
                   excursions permitted between 15 - 30°C (59 - 86°F).

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27140

    5011316

    ©2008 Merz Pharmaceuticals

    Rev. 5/08 Printed in U.S.A.



    Relabeling of "Additional Barcode" by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146

  • PRINCIPAL DISPLAY PANEL - 30g (tube) Carton

    NAFTIN®
    30g cream

    NAFTIFINE HCl 1% CREAM

    Rx Only

    30g (tube) Carton
  • INGREDIENTS AND APPEARANCE
    NAFTIN 
    naftifine hydrochloride cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2240(NDC:0256-4126)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAFTIFINE HYDROCHLORIDE (UNII: 25UR9N9041) (NAFTIFINE - UNII:4FB1TON47A) NAFTIFINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2240-21 in 1 CARTON
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01959906/17/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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