Label: LAMISIL AT- terbinafine hydrochloride aerosol, spray

  • NDC Code(s): 0067-6296-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 7, 2018

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) between the toes. Effectiveness on the bottom or sides of foot is unknown.
    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 the eyes
    for vaginal yeast infections

    When using this product

    do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
    do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120ºF (49ºC).

    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:
    wash the affected area with soap and water and dry completely before applying
    to open remove clear cap
    hold can 4" to 6" from skin.  Press and hold to spray a thin layer over affected area
    spray affected area once a day (morning or night) for 1 week or as directed by a doctor
    release to stop spray
    wipe excess from spray opening after each use
    return cap to can
    for athlete’s foot between the toes spray twice a day (morning and night) for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
    Image 1
    for jock itch and ringworm spray affected area 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

    store at 20 to 25°C (68 to 77°F)

  • Inactive ingredients

    ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

  • Questions?

    call 1-800-330-9876

  • Principal Display Panel

    NDC 0067-6296-01

    TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

    LAMISILAT®SPRAY

    Clinically proven to cure most athlete’s foot between the toes

    Full prescription strength

    Relieves itching, burning, cracking and scaling

     

    Net Contents 125 ml (4.2 fl oz)

    The only 1 week (twice a day)athlete’s foot spray

    Trademarks are owned by or licensed to the GSK group of companies.

    1-800-330-9876

    Distributed by:

    GSK Consumer Healthcare,

    Warren, NJ 07059

    ©2017 GSK or its licensor.

    13059

    13059_Lamisil AT Spray AF_4.2 oz.JPG
  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT
    terbinafine hydrochloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6296
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE0.84 g  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6296-01125 mL in 1 CAN; Type 0: Not a Combination Product03/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02112403/07/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)