PAIN GOODBYE MEDICATED CREAM (MENTHOL 5%) CREAM [AUSTIN BIOTECHNOLOGY INC]

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  • PAIN GOODBYE MEDICATED CREAM (MENTHOL 5%) CREAM [AUSTIN BIOTECHNOLOGY INC]

PAIN GOODBYE MEDICATED CREAM (MENTHOL 5%) CREAM [AUSTIN BIOTECHNOLOGY INC]
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NDC 15667-5049-4
Set ID e1072b73-6f3d-4cc1-b78d-e593193e0fd8
Category HUMAN OTC DRUG LABEL
Packager Austin Biotechnology Inc
Generic Name
Product Class
Product Number
Application Number PART348
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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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