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

  • NDC Code(s): 67777-201-08, 67777-201-09, 67777-201-10, 67777-201-11, view more
    67777-201-20, 67777-201-21
  • Packager: Dynarex
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 14, 2025

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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

    Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate Dihydrate, Glycerol, Isopropyl Myristate, Polyacrylic Acid (250000 MW), Polysorbate 80, Polyvinyl Alcohol, Propylene Glycol, Silicon Dioxide, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water

  • Questions and Comments?

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

  • Label

    1450_BX_MASTERCold Hot Medicated Patch 1450

  • Label

    1451_IN_MASTERCold Hot Medicated Patch 1451

  • Label

    1452_IN_MASTERCold Hot Medicated Patch 1452

  • 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)  
    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)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UREA (UNII: 8W8T17847W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-201-1036 in 1 CASE12/13/2019
    1NDC:67777-201-115 in 1 BOX
    1285 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:67777-201-2036 in 1 CASE12/13/2019
    2NDC:67777-201-215 in 1 BOX
    2285 mg in 1 PATCH; Type 0: Not a Combination Product
    3NDC:67777-201-0836 in 1 CASE12/13/2019
    3NDC:67777-201-093 in 1 BAG
    3285 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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