CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) LIQUID [CVS HEALTH]

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CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) LIQUID [CVS HEALTH]
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NDC 69842-374-01, 69842-374-06
Set ID ebb2dbf7-39b7-4a55-94ca-a5c1f420c8c5
Category HUMAN OTC DRUG LABEL
Packager CVS Health
Generic Name
Product Class
Product Number
Application Number PART348
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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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