Label: ATHLETES FOOT- terbinafin hydrochloride cream

  • NDC Code(s): 0067-6416-12
  • Packager: Novartis Cosnumer Health, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 19, 2009

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

  • Active ingredient

    Terbinafine hydrochloridel 1%

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  • Purpose

    Antifungal

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  • Uses

    • cures most athlete’s foot (tinea pedis)
    • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, burning, cracking and scaling which accompany these conditions
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  • Warnings

    For external use only

     Do not use

    • on nails or scalp
    • in or near the mouth or eyes
    • for vaginal yeast infections

    When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if too much irritation occurs or gets worse

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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  • Directions

    • adults and children 12 years and over
      • use the tip of the cap to break the seal and open the tube
      • wash the affected skin with soap and water and dry completely before applying
      • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
        • between the toes only: apply twice a day (morning and night) for 1 week or as

    directed by a doctor

    Image 1

    1 week between the toes

        • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
    • Image 2

      2 weeks on the bottom or sides of the foot

      • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
      • wash hands after each use
    • children under 12 years: ask a doctor

     

    Other information

    • do not use if seal on tube is broken or is not visible
    • store at controlled room temperature 20-25°C (68-77°F)

    Questions? call 1-800-452-0051

    100% Quality Guaranteed 888.309.9030

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  • Inactive ingredients

    benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol


    Distributed by DOLGENCORP, LLC,

    100 Mission Ridge

    Goodlettsville, TN 37072

    ©2009

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    terbinafin hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6416
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6416-12 12 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020980 08/31/2009
    Labeler - Novartis Cosnumer Health, Inc (879821635)
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