Label: AUVON PAIN RELIEF- menthol patch

  • NDC Code(s): 83391-002-01, 83391-002-02, 83391-002-03
  • Packager: SHENZHEN YUWEN E-COMMERCE CO., LTD.
  • 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 July 5, 2023

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  • SPL UNCLASSIFIED SECTION

    MENTHOL AUVON Pain Relief Patch

    Drug Facts

  • Active ingredients

    Menthol 5%

  • Purposes

    Topical Analgestic

  • Use

    Temporary relief from minor aches and paons of sore muscles and joints

  • Warnings

    For external use only

    Do not use

    • If you are allergic to the listed ingredients
    • If you are pregnent or breast feeding
    • If you are under 12 years of age
    • On wounds, cuts, damaged/broken/irritated skin
    • On eyes or mucous membranes 
    • With heating pads/devices or wrap with a bandage
    • With other topical analgesics
    • If the package arrives damaged or opened.

    When using this product

    ■ Use only as directed

    ■ Read and follow all directions and warnings on this label

    Stop use and ask a doctor if

    You are experiencing pain, swelling or blistering

    Redness is persent or irritation develops

    Symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep outof reach of children and pets.

    If ingested, get medical help or contact a Poison Control Center

    right away.

  • Directions

    ■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the other side of the film, and press the patch firmly to the skin.

    ■ Do not repeatedly use or repeatedly reapply the patch as far as possible

    ■ Cut first if if used on joints

    ■ Use in te affected area no more than 4 times daily

    ■ Wash hands with cool water after use

  • Storage

    • Avoid storing patches in direct sunlight
    • Protect patches from excessive moisture
  • Inactive ingredients

    Glycerin, sodium polyacrylate, dihydroxyaluminum aminoacetate,  methylparaben, propylparaben, polyacrylic acid, Kaolin, polysorbate 80, propylene glycol, tartaric acid, PVP, titanium dioxide, water, CMC, mineral oil, petrolatum,

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AUVON PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83391-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL470 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83391-002-011 in 1 POUCH; Type 0: Not a Combination Product07/05/2023
    2NDC:83391-002-028 in 1 BOX; Type 0: Not a Combination Product07/05/2023
    3NDC:83391-002-0315 in 1 BOX; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/05/2023
    Labeler - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)
    Registrant - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(83391-002)
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