Label: AMERIPATCH- menthol and capsaicin patch

  • Category: HUMAN OTC DRUG LABEL

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 18, 2015

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  • ACTIVE INGREDIENTS:

    Menthol 5.00%
    Capsaicin 0.0375%

  • PURPOSE

    Analgesic/Counterirritant
    External Analgesic

  • USES:

    Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

  • 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 a 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 - AmeriPatch (69418-003-15)

    FrontBack

  • INGREDIENTS AND APPEARANCE
    AMERIPATCH 
    menthol and capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-003
    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)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69418-003-153 in 1 BOX
    15 in 1 POUCH
    115 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 finalpart34801/31/2015
    Labeler - Meds Direct Rx, Inc. (064053428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co. Ltd529128763manufacture(69418-003)
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