PAINKOOLERS TOPICAL ANALGESIC PATCH (MENTHOL AND CAPSAICIN) PATCH [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]

PAINKOOLERS TOPICAL ANALGESIC PATCH (MENTHOL AND CAPSAICIN) PATCH [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]
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NDC 70118-001-05
Set ID f34aa9d9-f64c-49f3-9e8b-feb7ad1316b0
Category HUMAN OTC DRUG LABEL
Packager GA Health and Beauty (FOSHAN) Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS:

    Menthol 5.00%
    Capsaicin 0.05%

  • 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.
    • Do not use if you are allergic to Menthol.
    • 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.
    • Or Rash, itching or excessive skin irritation occurs.

    Keep out of reach of children.

    Consult Physician for children under 12.

  • 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 area of pain
    Apply to affected area not more than 3 times daily
    Wash hands with soap after applying patch
    Reseal pouch containing unused patches

  • OTHER INGREDIENTS:

    Water, Glycerine, Sodium Polyacrylate, Polyscorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diaxolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

  • Package Label

    Painkoolers

  • INGREDIENTS AND APPEARANCE
    PAINKOOLERS TOPICAL ANALGESIC PATCH 
    menthol and capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70118-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    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:70118-001-055 in 1 POUCH
    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 finalpart34809/21/2015
    Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)

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