Label: LAMISIL AT- terbinafine hydrochloride aerosol, spray

  • NDC Code(s): 0067-6297-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 16, 2021

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  • Active ingredient

    Terbinafine hydrochloride 1%

  • Purpose

    Antifungal

  • Uses

    •
    cures most jock itch (tinea cruris)
    •
    relieves itching, burning, cracking, and scaling which accompany this condition
  • 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
    •
    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 0067-6297-01

    TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

    LAMISILAT®

    SPRAY for JOCK ITCH

    Cures most jock itch

    For effective relief of itching and burning

    Net Contents 125 ml (4.2 fl oz)

    1-800-330-9876

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2017 GSK or its licensor.

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

    13058

    13058_Lamisil AT Spray JI 6297_4.2 oz.JPG
  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT
    terbinafine hydrochloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6297
    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:0067-6297-01125 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)
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