Label: HOT/COLD MEDICATED PATCH- hot cold patch patch

  • NDC Code(s): 67777-201-10, 67777-201-11, 67777-201-20, 67777-201-21
  • Packager: Dynarex
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 27, 2023

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  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Use

    Temporarily relieves minor aches and pains of muscles and joints due to

    • Arthritis
    • Simple backache
    • Strains
    • Sprains
    • Bruises
  • Warnings

    For external use only

    Do not use

    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product

    When using this product

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashes

    Stop use and ask a doctor if

    • Excessive redness or irritation is present
    • Conditions worsen
    • Symptoms persist for more than 7 days or 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 (1-800-222-1222) 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
    • Wear each patch up to 8 hours maximum

    Children under 12 years of age, consult a doctor

  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients

    Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate 80, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions and Comments?

    1-888-396-2739 Monday - Friday 9AM - 5PM EST

  • Label

    1451 IN MASTER1451 Hot Cold Medicated Patch

  • Label

    1452 IN MASTER1452 Hot Cold Medicated Patch

  • INGREDIENTS AND APPEARANCE
    HOT/COLD MEDICATED PATCH 
    hot cold patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL285 mg  in 5700 mg
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-201-10180 in 1 CASE12/13/2019
    1NDC:67777-201-115 in 1 BOX
    1285 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:67777-201-20180 in 1 CASE12/13/2019
    2NDC:67777-201-215 in 1 BOX
    2285 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/13/2019
    Labeler - Dynarex (008124539)
    Registrant - Dynarex (008124539)
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