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
  • 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 March 13, 2020

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

  • Drug Facts

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves 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, aluminum glycinate, kaolin, methylparaben, propylparaben, alcohol, titanium dioxide, tartaric acid, sorbitan monooleate, polysorbate 80, purified water

  • 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

  • Packaging

    Analg1

  • 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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TARTARIC ACID (UNII: W4888I119H)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    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 not finalpart34806/21/2017
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(52000-032)