Label: LAMISIL AT CONTINUOUS SPRAY- terbinafine hydrochloride liquid

  • NDC Code(s): 0067-6292-83
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 01/10

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  • Active ingredient

    Terbinafine hydrochloride

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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 this condition
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  • Warnings

    For external use only

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  • Do Not Use

    • on nails or scalp
    • in or near the mouth or the eyes
    • for vaginal yeast infections
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  • When using this product

    do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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  • Stop use and ask a doctor

    if too much irritation occurs or gets worse.

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  • 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 8° - 25° C (46° - 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

    Distr. By:  

     
    Novartis Consumer Health, Inc.
     
    Parsippany, NJ 07054-0622
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  • Principal Display Panel

    NDC 0067-6292-83

    TERBINAFINE HYDROCHLORIDE SOLUTION 1% - ANTIFUNGAL

    LAMISILAT®

    Spray

    Full prescription strength

    <DERMATOPHYTE LOGO & FOOT>

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

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  • Principal Display
  • INGREDIENTS AND APPEARANCE
    LAMISIL  AT CONTINUOUS SPRAY
    terbinafine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-6292
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 1.25 mL  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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021124 07/23/2009
    Labeler - Novartis Consumer Health, Inc. (879821635)
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