Label: CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF TOPICAL ANALGESIC- menthol, unspecified form liquid

  • NDC Code(s): 69842-374-01, 69842-374-06
  • Packager: CVS Health
  • 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 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 16.0%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporary relief of minor aches and pain muscles and joints associated with:

    ♦
    simple backache
    ♦
    arthritis
    ♦
    strains
    ♦
    bruises and sprains
    ♦
    cramps
  • Warnings

    For external use only. Test on a small patch of skin before applying generously.

    When using this product

    ♦
    Use only as directed
    ♦
    avoid contact with eyes
    ♦
    do not apply to wounds or damages skin
    ♦
    do not bandage tightly
    ♦
    do not use with heating pads or other heating devices
    ♦
    if redness is present, discontinue and consult a doctor
    ♦
    if skin irritation occurs, discontinue use

    Stop use and consult 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

    Flammable

    ♦
    keep away from fire or flame

    If pregnant or breast-feeding, as 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 older:

    ♦
    apply generously to affected area
    ♦
    massage into painful area until thoroughly absorbed into skin
    ♦
    repeat if necessary, but not more than 3 to 4 times daily
    ♦
    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    children under 12 years of age: ask a doctor

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Capsaicin, Citric Acid, Glycerin, Isopropyl Myristate, Propylene Glycol, Water.

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton

    ♥CVS
    Health™

    Compare to the active
    ingredient in Icy Hot®*

    MAXIMUM STRENGTH
    Cold & Hot
    PAIN RELIEF LIQUID

    MENTHOL 16%

    • No mess
    • Strong, quick relief
    • Roller ball applicator
      keeps hands clean
    • Stain free & fast drying

    Roll-on, easy
    applicator

    Actual Product Size
    on Side Panel

    2.5 FL OZ (73 mL)

    PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF   TOPICAL ANALGESIC
    menthol, unspecified form liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-374
    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 Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Alcohol (UNII: 3K9958V90M)  
    Capsaicin (UNII: S07O44R1ZM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-374-061 in 1 CARTON01/01/2014
    1NDC:69842-374-0173 mL in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/01/2014
    Labeler - CVS Health (062312574)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(69842-374)
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