Label: LAMISIL AT- terbinafine hydrochloride cream

  • NDC Code(s): 0067-8100-12, 0067-8100-15, 0067-8100-30
  • 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 8, 2020

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

  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • 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
  • 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.

  • 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
  • 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)
  • 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

    NDC 0067-8100-30

    TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL
    gsk

    LAMISILAT ® CREAM

    Relieves Itching, Burning, Cracking and Scaling
    NET WT 30 g (1 oz)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LAMISIL AT 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride1 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:0067-8100-121 in 1 CARTON07/02/2007
    112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0067-8100-301 in 1 CARTON07/02/2007
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0067-8100-151 in 1 CARTON04/24/2017
    315 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)