Label: CVS HEALTH PAIN RELIEF FOOT- menthol, unspecified form cream

  • NDC Code(s): 66902-292-04
  • Packager: NATURAL ESSENTIALS, INC.
  • 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 October 22, 2021

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  • Active ingredient

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Uses:

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

    • arthritis
    • backache
    • strains
    • sprains
  • Warnings:

    For external use only

    Ask a doctor before use if you have: Sensitive skin

    Flammable: Keep away from excessive heat or open flame.

    When using this product:

    • Avoid contact with the 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
    • Wash hands after use with cool water
    • Do not use with heating pad or device
    • Store in a cool dry place, away from sunlight

    Stop use and ask a doctor if:

    • Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

    If pregnant or breastfeeding:

    Ask a health professional before use.

    Keep out of reach of children and pets: If accidentally ingested, get medical help or contact a Poison Control Center immediately

  • Directions:

    Adults and Children 12 years of age and older:

    • Rub a thin film over affected areas not more than 4 times daily; massage not necessary
    • Children under 12 years of age: Consult physician
  • Inactive Ingredients:

    Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguarensis Leaf Extract, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Oil, Water.

  • Principal Display Panel – 113.3 g Tube Label

    cvs
    Health    ®

    Compare to the active ingredient in Biofreeze® Pain Relieving Foot Cream*

    Pain Relieving Foot Cream

    MENTHOL 10%

    • Temporarily relieves painful, achy feet
    • Soothes aggravated nerves

    NET WT 4 OZ (113.3 g)

    Principal Display Panel – 113.3 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH PAIN RELIEF FOOT 
    menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-292
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-292-04113 g in 1 TUBE; Type 0: Not a Combination Product10/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/22/2021
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-292)
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