Label: LAMISIL AT CONTINUOUS- terbinafine hydrochloride liquid

  • NDC Code(s): 0067-6292-83
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 15, 2018

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

  • Active ingredient

    Terbinafine hydrochloride 1%

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  • Purpose

    Antifungal

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  • 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
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  • 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 120 ºF (49 ºC).

    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.  

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  • 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.
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    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
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  • Other information

    store at 20 - 25°C (68 - 77°F)

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  • Inactive ingredients

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

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  • Questions?

    call 1-800-452-0051

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  • Principal Display Panel

    NDC 0067-6292-83

    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

    Lamasil Continuous Spray AF_4.2 fl oz.JPG
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  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT CONTINUOUS
    terbinafine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6292
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 0.84 g  in 125 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-6292-83 125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/23/2009 09/30/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021124 07/23/2009 09/30/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    Name Address ID/FEI Business Operations
    Novartis Pharma AG 482347168 API MANUFACTURE(0067-6292) , ANALYSIS(0067-6292)
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Ltd. 832224526 MANUFACTURE(0067-6292) , ANALYSIS(0067-6292) , PACK(0067-6292) , LABEL(0067-6292)
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Ltd. 832224591 PACK(0067-6292)
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