Label: PAINKOOLERS- menthol, capsaicin 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 12, 2021

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

  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    Menthol  5.00%

    Capsaicin 0.0375%

    Purpose

    Analgesic/Counterirritant

    External Analgesic

  • USES:

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

  • WARNINGS:

    • For external use only.  Use only as directed.  Avoid contact with eyes and mucous membranes.
    • Do not cover with bandage.

    Do not use

    • on wounds or damaged skin.
    • in combination with any other external analgesic products.
    • in combination with any external heat source.
    • on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
    • if you are allergic to Menthol.

    Keep out of reach of children.

    Consult physician for children under 12.

    Stop use and ask a doctor

    • if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
    • if rash, itching or excessive skin irritation occurs.
  • DIRECTIONS:

    • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
    • Children under 12 years, consult physician before use.
    • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to the area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
    • Reseal pouch containing unsed patches
  • OTHER INGREDIENTS:

    Water, Glycerine, Sodium Polyacrylate, Polysorbate 80Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

  • Store

     below 25 degrees.  Avoid direct sunlight.

  • Product Label

    PainKoolers Topical Analgesic patch Menthol 5% Capsaicin 0.0375% Designed for better mobility 5 Patches

    PainKoolersPatch

  • INGREDIENTS AND APPEARANCE
    PAINKOOLERS 
    menthol, capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-828
    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:65121-828-055 in 1 BOX02/10/2017
    18 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/30/2014
    Labeler - Pure Source, LLC (080354456)