Label: TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/11

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Terbinafine hydrochloride 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 the eyes
    • for vaginal yeast infections

    When using this product do not get into the 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 older
    • 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.
      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
    • 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
    1 week
    between the toes
    2 weeks on the bottom
    or sides of the foot
    Figure Figure
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  • 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)
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

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

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  • Questions?

    Call 1-800-200-6313

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OHIO 43017

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  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Leader®

    CURES MOST ATHLETE'S FOOT
    Athlete's Foot Cream
    Terbinafine Hydrochloride Cream 1%
    Antifungal Cream

    SATISFACTION
    • GUARANTEED •

    NET WT 1/2 oz (15 g)

    Principal Display Panel - 15 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-941
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 1 g  in 100 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)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-941-99 1 in 1 CARTON
    1 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077511 07/02/2007
    Labeler - Cardinal Health (097537435)
    Registrant - Taro Pharmaceuticals Inc. (206263295)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(37205-941)
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