Label: CVS PAIN RELIEF- menthol 10.5% spray

  • 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 14, 2022

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  • ACTIVE INGREDIENT

    Menthol 10.5%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

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

    Arthritis

    Backache

    Strains

    Sprains

  • WARNINGS

    For external use only

    Flammable: Keep away from excessive heat or open flames. Contents Under Pressure.

    Do Not Puncture Or Incinerate

    Do Not Store At Temperature Above 120°F

  • ASK DOCTOR

    Ask a Doctor before using if you have sensitive skin

  • WHEN USING

    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

    Do not bandage

    Do not use with heating pad or device

    Store in a cool dry place away from sunlight

    Wash hands after use with cool water

  • STOP USE

    Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Spray on to the affected areas not more than 4 times daily; message not necessary

    Children under 12 years of age: Consult physician

  • INACTIVE INGREDIENT

    Aloe Barbadensis leaf Juice, Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Dimethyl Sulphone (MSM), Isobutane, Propylene Glycol, SD Alcohol 40 B (30%), Water

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    CVS PAIN RELIEF 
    menthol 10.5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOBUTANE (UNII: BXR49TP611)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-996-1085 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/13/2022
    Labeler - CVS (062312574)
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