Label: HOT COLD MEDICATED PATCHES patch

  • NDC Code(s): 83559-003-01
  • Packager: Henan Enokon Medical Instrument Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Use

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

  • Warnings

    For external use only

  • Do not use

    ■ on wounds or damaged skin with a heating pad
    ■ if you have ever had an allergic reaction to this product or any of its ingredients

  • When Using

    When using this product
    ■ use only as directed
    ■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly

  • Stop Use

    Stop use and ask a doctor if
    ■ localized skin reactions occur, such as rash, itching, redness, irritation pain swelling and blistering
    ■ conditions worsen
    ■ symptoms persist for more than 7 days
    ■ symptoms clear up and occur again within a few days

  • Ask Doctor

    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 of age and over:
    ■ clean and dry affected area
    ■ remove film from patch and apply to the skin
    ■ apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    ■ remove patch from the skin after at most 8 hours of application
    Children under 12 years of age: consult a doctor

  • Other information

    ■ avoid storing product in direct sunlight
    ■ protect product from excessive moisture
    ■ store at 20-25°C(68-77°F)

  • Inactive ingredients

    Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions

    Call 718-975-2586

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HOT COLD MEDICATED PATCHES 
    hot cold medicated patches patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    POVIDONE (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83559-003-012 in 1 BAG; Type 0: Not a Combination Product04/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/07/2024
    Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Enokon Medical Instrument Co Ltd.701730676manufacture(83559-003)