Label: COLD AND HOT MEDICATED LARGE- menthol patch

  • NDC Code(s): 52000-033-41
  • 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 aches and pains of muscles and joints due to
    • simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps

  • WARNINGS:

    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 (1-800-222-1222) immediately.

  • 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 to 4 times daily

    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%

    Pain relieving ointment on a breathable adhesive pad

    EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.

    FAST RELIEF OF MINOR ACHES AND PAINS

    *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-rev5

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED LARGE 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM428.5 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:52000-033-411 in 1 BOX06/21/2017
    11 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(52000-033)