Label: PAIN GOODBYE MEDICATED CREAM- menthol 5% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 10, 2013

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  • ACTIVE INGREDIENTS

    Menthol             5%

  • PURPOSE

    Menthol    External Analgesic

  • USES

    Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis and strains.

  • WARNINGS

    Use only as directed. For External Use Only. Avoid contact with eyes, mucous membrances, rashes, wounds or damaged skin. Package not child resistent, in case of accidental ingestion, contact doctor immediately.

  • WARNINGS

    Keep out of reach of children.

  • WARNINGS

    Do not apply on nose and genital area. If rashes, redness and itchness result, discontinue use and consult a doctor.

  • WARNINGS

    If prone to allergic reaction to the product, consult a doctor before using.

  • DIRECTION

    Adult and children 12 years of age and older; apply a few drops to affected area and rub gently 3 to 4 times daily. Children under age of 12, do not use, consult a doctor.

  • INACTIVE INGREDIENTS

    Peppermint Oil, Eucolyptus Oil, Lavendor Oil, Clove oil, Jasmine Lactone, Stearic Acid, Glyceryl monostearate, Carbomer

  • PRINCIPAL DISPLAY PANEL

    carton.jpg

  • INGREDIENTS AND APPEARANCE
    PAIN GOODBYE MEDICATED CREAM 
    menthol 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15667-5049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14 g  in 280 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JASMINE LACTONE (UNII: H8558L43SR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15667-5049-4280 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/26/2011
    Labeler - Austin Biotechnology Inc (656001949)
    Registrant - Austin Biotechnology Inc (656001949)
    Establishment
    NameAddressID/FEIBusiness Operations
    Austin Biotechnology Inc656001949manufacture(15667-5049)
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