Label: LAMISIL AT- terbinafine hydrochloride cream

  • NDC Code(s): 0067-3998-30, 0067-3998-42
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 25, 2024

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 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

    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)
  • 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

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks owned or licensed by GSK. 2019 GSK or licensor.

  • Principal display panel

    NDC 0067-3998-30

    LAMISIL AT Cream

    gsk

    TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

    FOR ATHHLETE’S FOOT

    NET WT 30 g (1 oz)

    13508 Front

    13508 Lamisil AT 30g (1 oz)
  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-3998
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE10 mg  in 1 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-3998-421 in 1 CARTON08/10/200511/30/2025
    112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0067-3998-301 in 1 CARTON08/10/200511/30/2025
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02098008/10/200511/30/2025
    Labeler - Haleon US Holdings LLC (079944263)