Label: COLD/HOT MEDICATED PATCHES- medicated patches 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 November 7, 2018

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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
    • symptoms clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    If swallowed, get medical help or contact a Poison Control Center 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, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

  • Label NDC 67777-145-10

    NDC 67777-145-10

  • Label NDC 67777-145-20

    NDC 67777-145-20

  • Label NDC 67777-145-30

    NDC 67777-145-30

  • INGREDIENTS AND APPEARANCE
    COLD/HOT MEDICATED PATCHES 
    medicated patches patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 5 mg
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-145-10180 in 1 CASE08/15/2018
    15 in 1 BOX
    15 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:67777-145-20180 in 1 CASE08/15/2018
    25 in 1 BOX
    25 mg in 1 PATCH; Type 0: Not a Combination Product
    3NDC:67777-145-30108 in 1 CASE08/15/2018
    33 in 1 BOX
    35 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 finalpart34808/15/2018
    Labeler - Dynarex Corporation (008124539)
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