Label: ULTIMATE TOPICAL PAIN RELIEF PATCH- capsaicin and menthol, unspecified form patch

  • NDC Code(s): 69159-910-05
  • Packager: Foshan Aqua Gel Biotech Co.,Ltd.
  • 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 6, 2017

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  • 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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