Label: LAMISIL AT- terbinafine hydrochloride cream

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

Drug Label Information

Updated December 19, 2018

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

  • 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 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
        • 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
    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)
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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 or comments?

    call 1-800-330-9876

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  • SPL UNCLASSIFIED SECTION

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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  • PRINCIPAL DISPLAY PANEL

    DRUG: Lamisil AT

    GENERIC: Terbinafine Hydrochloride

    DOSAGE: CREAM

    ADMINSTRATION: TOPICAL

    NDC: 70518-1736-0

    COLOR: white

    PACKAGING: 30 g in 1 TUBE

    OUTER PACKAGING: 1 in 1 CARTON

    ACTIVE INGREDIENT(S):

    • Terbinafine Hydrochloride 1g in 100g

    INACTIVE INGREDIENT(S):

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

    Remedy_Label

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  • INGREDIENTS AND APPEARANCE
    LAMISIL AT 
    terbinafine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-1736(NDC:0067-8100)
    Route of Administration TOPICAL
    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:70518-1736-0 1 in 1 CARTON 12/15/2018
    1 30 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
    ANDA ANDA077511 12/15/2018
    Labeler - REMEDYREPACK INC. (829572556)
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