Label: LAMISIL AT TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream

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

Drug Label Information

Updated August 16, 2024

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

  • ACTIVE INGREDIENT

    Terbinafine hydrochloride 1%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    - cures most athlete's foot (tinea pedis)

    - cure most jock itch (tinea cruris) and ringworm (tinea corporis)

    - relieves itching, burning, cracking andf scaling which accompany this condition

  • 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

    do not get into eyes. If eye contact occurs, rinse thoroughly with water

  • STOP USE

    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

  • Other Information

    - do no use if seal on tube is broken or is not visible

    - store at controlled room temperature 20-25C (68-77F)

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    call 1-888-544-1880

  • PRINCIPAL DISPLAY PANEL

    Lamisil AT Cream

    Terbinafine Hydrochloride Cream 1% - Antifungal

    For Athlete's Foot

    NET WT 30 g (1 oz)

    Tube

    Carton

  • INGREDIENTS AND APPEARANCE
    LAMISIL AT TERBINAFINE HYDROCHLORIDE 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-139
    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
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-139-011 in 1 CARTON08/21/2024
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02098008/21/2024
    Labeler - Voyant Beauty, Inc. (243547333)