Label: LAMISIL AT FOR JOCK ITCH- terbinafine hydrochloride cream

  • NDC Code(s): 0067-8114-12
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    •
    cures most jock itch (tinea cruris)
    •
    relieves itching, burning, cracking and scaling which accompany this condition
  • 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.

  • 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
    •
    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 to 25°C (68 to 77°F)
  • Inactive ingredients

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

  • Questions or comments?

     
    call 1-800-330-9876
  • SPL UNCLASSIFIED SECTION

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    NDC 0067-8114-12

    TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

    LAMISILAT ®

    CREAM for
    JOCK ITCH

    Relieves itching and burning

    NET WT. 12 g (.42 oz)

    Principal Display Panel - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LAMISIL AT  FOR JOCK ITCH
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8114-121 in 1 CARTON07/02/2007
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07751107/02/2007
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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