Label: CVS PAIN RELIEF- menthol 4% gel

  • 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 September 28, 2022

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  • ACTIVE INGREDIENT

    Menthol 4%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporary relief from minor aches and pains of sore muscles and joints associated with:

    arthritis

    backache

    strains

    sprains

  • WARNINGS

    For external use only

    Flammable: Keep away from excessive heat or open flame

    Ask a doctor before use if you have: sensitive skin

    Stop use and ask a doctor if

    condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

    When using this product

    Use only as directed

    Avoid contact with eyes or mucous membranes

    Do not apply to wounds or damaged skin

    Do not use with other ointments, creams, sprays or liniments

    Do not apply to irritated skin or if excessive irritation develops

    Do not bandage or use with heating pad or device

    Store in a cool dry place away from direct sunlight

    Wash hands after use with cool water

    If pregnant or breastfeeding, ask a health professional before use

    Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older: Rub a thin film over affected areas not more than daily: massage not necessary

    Children under 2 years of age : Consult physician

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Dimethyl Sulphone (MSM), Glycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    CVS PAIN RELIEF 
    menthol 4% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-997-0485 g in 1 TUBE; Type 0: Not a Combination Product09/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/29/2020
    Labeler - CVS (062312574)
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