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Revalife (International Nutraceutical Company of America (INCA), LLC)

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OINTMENT 85 g in 1 TUBE (42452-378-49) Label Information

Complete Revalife Information

  • ACTIVE INGREDIENT

    Active Ingredient : Menthol 3%


  • PURPOSE

    Purpose-Topical Analgesic


  • INDICATIONS & USAGE

    Uses-Temporarily relieves minor pain of joints and muscles associated with arthritis, bursitis, tendonitis, strains


  • DOSAGE & ADMINISTRATION

    Directions: Apply to clean, dry skin over painful joint or muscle gently massaging until cream disappears.  For optimum results use daily for 30 days and continue to use daily thereafter.  Repeat as neccessary.  Close cap tightly after use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


  • WARNINGS

    For external use only.  Do not bandage tightly or use with a heating pad.  Avoid contact with mouth, eyes, and mucous membranes. Do not apply to wounds, damaged, broken, or irritated skin.

    Stop use and ask a doctor if: Symptoms persists over 7 day or clear up and occur again within a few days.  Redness is present or irritation develops. Using on a child 12 years of age or under.


  • INACTIVE INGREDIENT

    Inactive Ingredients: EDTA, Ethanol,  Isopropyl palmitate, Methyl Paraben, Monosodium Phosphate, N-Acetyl Glucosamine, Poloxamer 407, Propyl Paraben,  Soy Lecithin, Todopherol Acetate (Vitamin E), Water


  • If pregnant or breast feeding, ask a health professional before use


  • INGREDIENTS AND APPEARANCE
    REVALIFE 
    topical menthol ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42452-378
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 937.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42452-378-48 1 in 1 CARTON 01/26/2012
    1 NDC:42452-378-49 85 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/26/2012
    Labeler - International Nutraceutical Company of America (INCA), LLC (941002250)
    Registrant - International Nutraceutical Company of Americe (INCA), LLC (941002250)