Label: CVS HEALTH ROLL-ON FOOT PAIN RELIEF- menthol, unspecified form 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 July 26, 2021

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  • Active ingredient

    Menthol 4%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • Warnings

    For external use only

    Flammable: Keep away from fire or flame and heated surfaces

    Do not use

    • if you are allergic to any ingredient in this product
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device

    When using this product

    • do not bandage tightly
    • do not use otherwise than as directed
    • avoid contact with eyes or mucous membranes
    • rare cases of burns have been reported with products of this type
    • if severe burning sensation occurs, discontinue use immediately

    Stop use and ask a doctor if

    • condition worsens
    • rash, itching, redness or excessive irritation of the skin develops
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over:

    • apply to affected area using roller ball not more than 4 times daily
    • massage painful area until absorbed into skin
    • wash hands after each use with cold water

    Children under 12 years of age:

    • consult a doctor
  • Other information

    • store in a cool place away from direct sunlight
    • store with cap closed tightly
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camelia Sinensis (Green Tea) Extract, Camphor, Carbomer 940, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

  • Principal Display Panel – 74 mL Bottle Label

    CVS
    Health®

    Roll-On
    Foot Pain
    Relief

    MENTHOL 4%

    • Temporarily relieves
      painful, achy feet
    • Soothes
      aggravated
      nerves

    2.5 FL OZ (74 mL)

    Principal Display Panel – 74 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ROLL-ON FOOT PAIN RELIEF 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-919
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM36 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-919-0374 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2020
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-919)
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