Label: LAMISIL- terbinafine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 1, 2010

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

View All Sections
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6105(NDC:0067-6293)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE1.25 mL  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:54868-6105-0125 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02112404/13/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!