Label: CAPMENT- menthol, capsaicin patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 25, 2015

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  • Active ingredients:

    Capsaicin 0.0375%

    Menthol 5.00%

  • Purpose

    Topical Anesthetic

    Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Consult physician for children under 12.

  • Uses

    For the temporary relief of minor aches and muscle pain associated with arthritis, simple backache, strains, muscle soreness and stiffness.

  • Warnings

    • Only for external use. Use only as directed or by a health professional.
    • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
    • Do not cover with bandage.
    • Consult your physician: If pregnant or pain persists or worsens.
  • Directions

    Adults and children 12 and over: Apply patch to affected area 1 to 2 times daily or as directed.

    Instructions for Use:

    • Clean and dry affected area
    • Open pouch and remove on patch
    • Remove any protective film and apply directly to affected area of pain
    • Wash hands with soap and water after applying patch
    • Reseal pouch containing unused patches after each use
  • Other Ingredients:

    WATER, GLYCERIN, SODIUM POLYACRYLATE (2500000 MW), POLYSORBATE 80, ALOE VERA LEAF, EDETATE DISODIUM, DIAZOLIDINYL UREA, METHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, PROPYLPARABEN

  • STORAGE AND HANDLING

    Store in a dry, cool place

  • Packaging

    Capment

  • INGREDIENTS AND APPEARANCE
    CAPMENT 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69650-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.04   in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.00375   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69650-001-1515 in 1 BOX
    1NDC:69650-001-051 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/24/2015
    Labeler - Original Patch Company Inc (079705068)
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