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Lamisil (Physicians Total Care, Inc.)

Available Formats

Dosage Form Package Information Links
SPRAY 125 mL in 1 BOTTLE, SPRAY (54868-6105-0) Label Information

Complete Lamisil Information

  • Active ingredient

    Terbinafine hydrochloride


  • 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.


  • 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 8° - 25° C (46° - 77° F)


  • Additional Information

    Full Prescription Strength

    Continuous Spray Action

    Cures Most Jock Itch

    For Effective Relief of Itching & Burning

    Distr. By:  

     
    Novartis Consumer Health, Inc.
     
    • Parsippany, NJ 07054-0622 ©2009

  • Inactive ingredients

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


  • Questions

    call 1-800-452-0051 or visit us at www.lamisilat.com


  • Principal Display

    Relabeling of "Additional Barcode" by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146

    NDC 54868-6105-0
    Lamasil At Continuous Spray


  • INGREDIENTS AND APPEARANCE
    LAMISIL 
    terbinafine hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6105(NDC:0067-6293)
    Route of Administration TOPICAL
    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:54868-6105-0 125 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021124 04/13/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel