Label: COLD AND HOT PAIM RELIEVING CAREONE- menthol 16.00% 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 9, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                               Purpose

    Menthol 16%.....................................................Topical analgesic

  • PURPOSE

  • Uses

    temporarily relieves minor aches and pains of muscles
    and joints associated with: • arthritis • simple backache • strains
    • sprains • bruises

  • WARNINGS


    For external use only.
    When using this product • use only as directed • do not
    bandage tightly or use with a heating pad • avoid contact with
    eyes and mucous membranes • do not apply to wounds or
    damaged, broken or irritated skin • if you experience pain,
    swelling, or blistering of the skin where an OTC topical muscle
    and joint pain reliever was applied, stop using the product and
    seek medical attention immediately. These products should not
    cause pain or skin damage.
    Stop use and ask 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

  • 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 to affected area 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

  • Inactive ingredients

     Acrylates/C10-30 Alkyl
    Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate,
    Propylene Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT PAIM RELIEVING  CAREONE
    menthol 16.00% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Capsaicin (UNII: S07O44R1ZM)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-777-031 in 1 CARTON07/14/2015
    173 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/14/2015
    Labeler - CareOne (809183973)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41520-777) , label(41520-777)