Label: LIDOCAINE PAIN RELIEF PATCH- lidocaine and menthol, unspecified form patch

  • NDC Code(s): 69159-920-05
  • 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

    Lidocaine 4%

    Menthol 1%

  • Purpose:

    Topical anesthetic

    Topical anesthetic

  • Uses:

    For the temporary relief of pain.

  • Warnings

    For external use only
    Avoid contact with eyes.

    Do not use

    • if you are allergic to any active and inactive ingredients listed in this patch
    • if pouch is damaged or opened
    • on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin
    • for more than one week without consulting a doctor.

    When using this product

    • use only as directed. Read and follow all directions and warnings on this package
    • do not allow contact with eyes or mucous membranes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • do not reuse patch
    • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

    Stop use and ask a doctor if

    • conditions worsens
    • rash, itching or skin irritation develops
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

    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 over 12 years of age:

    • clean and dry affected area
    • strip off the clear protective film and place adhesive patch over affected area
    • leave in place for up to 8 hours
    • wash hands thoroughly after applying or removing patch.

    Children under 12 years: ask a doctor before use.

  • Other Information

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

  • Inactive Ingredients:

    dihydroxyaluminum aminoacetate, glycerin,kaolin,methylparaben,polyacrylic acid,polysorbate 80,propylene glycol,propylparaben, povidone,sodium polyacrylate, tartaric acid,tatanium dioxide,water.

  • Questions or Comments?

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

  • Dosage and Administration

    Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.

  • Lidocaine Pain Relief Patch

    package

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF PATCH 
    lidocaine and menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69159-920
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69159-920-051 in 1 CARTON09/01/2016
    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 finalpart34809/01/2016
    Labeler - Foshan Aqua Gel Biotech Co.,Ltd. (529128763)
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