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PAIN GOODBYE MEDICATED CREAM (Austin Biotechnology Inc)

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CREAM 280 g in 1 BOTTLE, PLASTIC (15667-5049-4) Label Information

Complete PAIN GOODBYE MEDICATED CREAM Information

  • 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


  • INGREDIENTS AND APPEARANCE
    PAIN GOODBYE MEDICATED CREAM 
    menthol 5% cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:15667-5049
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14 g  in 280 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15667-5049-4 280 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/26/2011
    Labeler - Austin Biotechnology Inc (656001949)
    Registrant - Austin Biotechnology Inc (656001949)
    Establishment
    Name Address ID/FEI Business Operations
    Austin Biotechnology Inc 656001949 manufacture(15667-5049)