Label: CVS HEALTH COLD AND HOT ROLL-ON MENTHOL- menthol, unspecified form liquid

  • 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 January 17, 2019

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  • Active ingredient:

    Menthol 16%

  • Purpose:

    Topical analgesic

  • Uses:

    • temporarily relieves minor pain associated with:
      • arhtritis
      • simple backache
      • muscle strains
      • sprains
      • bruises
      • cramps
  • Warnings:

    For external use only.

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label.
    • rare cases of serious burns have been reported with products of this type
    • do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning sensation occurs, discontinue use immediately
    • do not expose the area treated with product to heat or direct sunlight
    • avoid applying into skin folds.

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

    Flammable

    • Keep away from fire or flame.

    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 over 12 years:

    • apply a thin layer to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    Children 12 years or younger

    • ask a doctor
  • Other information:

    Store in a cool dry area. Close cap tightly after use.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Capsaicin, Deionized Water, Glycerin, Isopropyl Myristate, Propylene Glycol, SDA 40-2 Alcohol.

  • Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

    CVS
    Health™

    Compare to the active
    ingredient in Maximum
    Strength IcyHot®
    Pain Relieving Liquid

    MAXIMUM STRENGTH

    Cold & Hot
    Roll-On

    MENTHOL 16%

    Pain-relieving liquid

    • Long-lasting formula
    • No-touch applicator
    • Dries quickly

    Actual Product Size
    on Side Panel

    2.5 FL OZ (73 mL)

    Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label
  • Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label

    CVS
    Health™

    MAXIMUM STRENGTH

    Cold & Hot
    Roll-On

    MENTHOL 16%

    Pain-relieving liquid

    • Long-lasting formula
    • No-touch applicator
    • Dries quickly

    2.5 FL OZ (73 mL)

    Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH COLD AND HOT ROLL-ON   MENTHOL
    menthol, unspecified form liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-241-251 in 1 BOX01/17/2018
    173 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/17/2018
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-241)
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