Label: CMX TOPICAL PAIN- menthol, capsaicin patch

  • NDC Code(s): 69889-027-15
  • Packager: Unik Pharmaceuticals, Inc
  • 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 February 10, 2017

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

  • DRUG FACTS:

  • Active Ingredient:

    Menthol 5.00%

    Capsaicin 0.0375%

    Topical Analgesic

    External Analgesic

  • Uses:

    For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings:

    • For external use only. Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not apply to open wounds or damaged skin.

    Do not use

    • in combination with any external heat source.
    • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar
    device or garment.

    Keep out of reach of children.

    • Consult physician for children under 12.
    • Do not use if allergic to Menthol.

    Stop use and consult physician

    • if symptoms worsen or persist for more than 7 days.

    • Stop use if itching to excessive skin irritation occurs.

    If pregnant or breast feeding

    • contact physician prior to use.

  • Directions:

    Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily.
    Children under 12, consult a physician before use.
    How to Apply:
    • Clean and dry affected area.
    • Remove patch from backing and apply directly to area of pain.
    • Do not apply to affected area more than three times daily.
    • Use only on patch at a time.
    • Wash hands with soap and water immediately after application.
    • Reseal pouch containing unused patches.

  • Other Ingredients:

    Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Polysorbate-80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium Salt, Diazolidinyl Urea, Methyl Paraben, Iodopropynyl Butylcarbamate, Propyl Paraben.

  • Store at room temperature.

    Avoid direct sunlight

  • Package Labeling:

    Patch

  • INGREDIENTS AND APPEARANCE
    CMX TOPICAL PAIN 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69889-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69889-027-1515 in 1 BOX09/15/2016
    18 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2016
    Labeler - Unik Pharmaceuticals, Inc (079835464)