Label: COLD AND HOT MEDICATED PATCH- menthol patch

  • NDC Code(s): 52000-032-42
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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

  • Drug Facts

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieve minor pain associated with:
    • arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps

  • 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 skin.

    Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops.

    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 older:

    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • should be used up to 8 hours
    • should be used no more than 3 times a day  
    • children under 12 years of age: consult a doctor
  • Other information

    • store at room temperature 68° to 77°F (20° to 25°C)
  • Inactive ingredients

    Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in Icy Hot® Patch

    EXTRA STRENGTH

    Contains Menthol 5%

    Works on contact for cooling pain relief

    Pain relieving ointment on a breathable adhesive pad

    *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

    Distributed by:

    Universal Distribution Center

    96 Distribution Boulevard • Edison, NJ 08817

    Made in P.R.C.

  • Packaging

    CHpatch-32

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM205.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALCOHOL 95% (UNII: 7528N5H79B)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-032-421 in 1 BOX06/21/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/21/2017
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Koolcare Technology Co., Ltd.602479389manufacture(52000-032)