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
  • 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 February 7, 2023

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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 not finalpart34807/01/2014
    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 not finalpart34812/01/2014
    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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