ULTIMATE TOPICAL PAIN RELIEF PATCH (CAPSAICIN AND MENTHOL, UNSPECIFIED FORM) PATCH [FOSHAN AQUA GEL BIOTECH CO.,LTD.]

ULTIMATE TOPICAL PAIN RELIEF PATCH (CAPSAICIN AND MENTHOL, UNSPECIFIED FORM) PATCH [FOSHAN AQUA GEL BIOTECH CO.,LTD.]
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NDC 69159-910-05
Set ID 33c9f8ba-903e-249e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Foshan Aqua Gel Biotech Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Menthol 5.00%

    Capsaicin 0.0375%

  • Purpose:

    External Analgesic/Counterirritant

    External Analgesic/Counterirritant

  • Uses:

    Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

  • Warnings

    • For external useonly.
    • Avoid contact with eyes and mucous membranes.
    • Do not use on wounds or damaged skin.
    • Do not cover with bandage.
    • Do not use if you are allergic to Menthol.
    • Consult physician for use on children under 12.

    Stop use and ask a doctor if

    conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,

    itching or excessive skin irritation occurs.

    If pregnant or breast feeding

    ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily
    • Children under 12 years: Consult physician before use.
  • Other Information

    Store below 25°C (77°F). Avoid direct sunilght.

  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

  • Questions or Comments?

    Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

  • Dosage and Administration

    Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol

  • Ultimate Topical Pain Relief Patch

    Box Image

  • INGREDIENTS AND APPEARANCE
    ULTIMATE TOPICAL PAIN RELIEF PATCH 
    capsaicin and menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-910
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69159-910-051 in 1 CARTON05/01/2016
    15 in 1 POUCH
    19 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 finalpart34805/01/2016
    Labeler - Foshan Aqua Gel Biotech Co.,Ltd. (529128763)

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