Label: LAMISIL AT JOCK ITCH- terbinafine hydrochloride cream

  • NDC Code(s): 0067-3999-42
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 15, 2021

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  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    •
    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
    •
     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.

    13510 (Front Carton)

  • Principal Display Panel

    NDC 0067-3999-42

    LAMISIL AT CREAM

    gsk

    TERBINAFINE HYDROCHLORIDE CREAM 1% - ANTIFUNGAL

    FOR JOCK ITCH

    NET WT 12 g (0.42 oz)

    13510 (Front Carton)

    13510 Lamisil AT JI 12g (0.42 oz)
  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT JOCK ITCH
    terbinafine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-3999
    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:0067-3999-421 in 1 CARTON12/08/2006
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02098012/08/2006
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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