Label: REVALIFE- topical menthol ointment

  • 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 December 6, 2017

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  • 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

  • PRINCIPAL DISPLAY PANEL

    Revalife 3 ounce tube carton

  • INGREDIENTS AND APPEARANCE
    REVALIFE 
    topical menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42452-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL937.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42452-378-481 in 1 CARTON01/26/2012
    1NDC:42452-378-4985 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/26/2012
    Labeler - International Nutraceutical Company of America (INCA), LLC (941002250)
    Registrant - International Nutraceutical Company of Americe (INCA), LLC (941002250)
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