Label: LAMISIL AT CREAM- terbinafine hydrochloride cream

  • NDC Code(s): 61047-120-01, 61047-120-02, 61047-120-03
  • Packager: KIK HOLDCO COMPANY INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 4, 2020

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

  • ACTIVE INGREDIENT

    Terbinafine hydrochloride 1%

    Antifungal

  • Uses

    - 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 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

  • 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 Ingredients

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

  • Questions or comments?

    call 1-800-330-9876

  • 12 g Tube with Carton - For Jock Itch

    Lamisil AT

    Cream Terbinafine Hydrochloride Cream 1% - Antifungal

    For JOCK ITCH

    - cures most jock itch

    - for effective relief of itching and burning

    NET WT

    12 g (0.42 oz)

    12g Tube Jock Itch

    JI_12g_Carton

  • 12 g Tube with Carton - For Athlete's Foot

    Lamisil AT Cream

    Terbinafine Hydrochloride Cream 1% - Antifungal

    For Athlete's Foot

    Net Wt

    12 g (0.42 oz)

    12 g Tube Foot12 g Carton Foot

  • 30 g Tube with Carton - For Athlete's Foot

    Lamisil AT Cream

    Terbinafine Hydrochloride Cream 1% - Antifungal

    For Athlete's Foot

    NET WT

    30 g (1 oz)

    30 g Tube Foot30 g Carton Foot

  • INGREDIENTS AND APPEARANCE
    LAMISIL AT CREAM 
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-120
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61047-120-011 in 1 CARTON02/24/2020
    112 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:61047-120-021 in 1 CARTON03/02/2020
    212 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:61047-120-031 in 1 CARTON02/20/2020
    330 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02098002/20/2020
    Labeler - KIK HOLDCO COMPANY INC. (243547333)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK HOLDCO COMPANY INC.243547333manufacture(61047-120)