Label: CVS PAIN RELIEF- menthol 4% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2024

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  • ACTIVE INGREDIENT

    Menthol 4%

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, bruises, and muscle strains.

  • WARNINGS

    For external use only.

    Flammable. Keep away from excessive heat or open flame.

    When using this product use only as directed. Avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin, do no apply to irritated skin or if excessive irritation develops, do not bandage tightly or use with heating pad or device. Children 12 years of age and older: use only under adult supervision.

    Stop use and ask a doctor if you experience pain, swelling, or blistering of the skin, condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children of 12 years: rub a thin film over affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. Wash hands after use with cool water.

  • INACTIVE INGREDIENT

    Carbomer, fragrance, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water.

  • PRINCIPAL DISPLAY PANEL

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    CVS PAIN RELIEF 
    menthol 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-161-0274 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2024
    2NDC:51316-161-0389 mL in 1 TUBE; Type 0: Not a Combination Product11/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/15/2024
    Labeler - CVS (062312574)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(51316-161)
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