Label: PAIN RELIEVING- lidocaine patch

  • NDC Code(s): 82865-002-01
  • Packager: UNIAID Health Management (Suzhou) Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • DRUG FACTS

  • Active ingredient

    Lidocaine 4.0%

    Purpose

    Topical anesthetic

  • Use

    For temporary relief of pain

  • WARNINGS

    For external use only

    Do not use

    • more than 1 patch at a time
    • with a heating pad
    • on wounds or damaged skin
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • do not bandage tightly
    • avoid contact with the eyes, mucous membranes or rashes

    Stop use and ask a doctor if 

    • symptoms persist for more than 7 days
    • conditions worsen
    • symptoms clear up and occur again within a few days
    • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

    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 years of age and over:

    • clean and dry affected area
    • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • remove film from patch and apply to the skin

    Children under 12 years of age: consult a doctor

  • OTHER INFORMATION

    • Store in a clean, dry place outside of direct sunlight, Protect product from excessive moisture
  • INACTIVE INGREDIENT

    Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Povidone K90, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • QUESTIONS?

    1-626-839-9001

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82865-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82865-002-016 in 1 BOX05/01/202202/14/2026
    11 in 1 BAG
    112 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/202202/14/2026
    Labeler - UNIAID Health Management (Suzhou) Co.,Ltd (412839778)
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