Label: COLD AND HOT MEDICATED- menthol patch

  • NDC Code(s): 10742-1117-1, 10742-1118-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active ingredient

    Menthol 5%

  • Purpose

    Menthol - Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to

    • arthritis
    • simple backache
    • strains
    • sprains
    • bursitis
    • tendonitis
    • bruises
    • cramps
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • avoid contact with eyes or on mucous membranes
    • do not apply to wounds or to damaged or very sensitive skin
    • do not bandage tightly or use with a heating pad

    Stop use and ask a doctor if

    • excessive redness or irritation is present
    • condition worsens
    • pain 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 and over: apply patch to affected area as needed but not more than 4 times daily
    • children under 12 years: ask a doctor
    • for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.
  • Inactive ingredients

    carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

  • Package/Label Principal Display Panel

    Cold and Hot Medicated Patch
  • Package/Label Principal Display Panel

    Drug Facts
  • Principal Display Panel

    Cold and Hot Medicated Patch
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1117-11 in 1 CARTON07/01/2014
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/01/2014
    COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM240 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1118-11 in 1 CARTON12/01/2014
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2014
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757label(10742-1117, 10742-1118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teikoku Seiyaku Co., Ltd.690849997manufacture(10742-1117, 10742-1118)
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