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

  • 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 May 26, 2022

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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)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-201-10180 in 1 CASE12/13/2019
    15 in 1 BOX
    1285 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:67777-201-20180 in 1 CASE12/13/2019
    25 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 not finalpart34812/13/2019
    Labeler - Dynarex (008124539)
    Registrant - Dynarex (008124539)
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