Label: LAMISIL AT CONTINUOUS SPRAY- terbinafine hydrochloride liquid 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/10

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

  • 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 LABEL Item Code (Source) NDC:0067-6292
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 1.25 mL  in 125 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    POLYOXYL 20 CETOSTEARYL ETHER  
    PROPYLENE GLYCOL  
    WATER  
    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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