PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE, LLC]

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PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE, LLC]
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NDC 65121-828-05
Set ID f8f8d9b6-0781-4a42-ab03-3fd2e8ea59ba
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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)
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