Label: LIDOCAINE PAIN RELIEF PATCH patch

  • NDC Code(s): 83559-004-01
  • Packager: Henan Enokon Medical Instrument Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical analgesic

  • Use

    For temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    more than 1 patch at a time
    on wounds or damaged skin
    with a heating pad
    if you have ever had an allergic reaction to this product or any of its ingredients

  • When Using

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

  • Stop Use

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

  • Ask Doctor

    If pregnant or breast-feeding, ask a health professional before use.
    Children under 12 years of age: consult a doctor

  • 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
    remove film from patch and apply to the skin (see illustration)
    apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    remove patch from the skin after at most 8 hours of application
    Children under 12 years of age: consult a doctor

  • Other information

    avoid storing product in direct sunlight
    protect product from excessive moisture
    store at 20-25°C(68-77°F)

  • Inactive ingredients

    Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

  • Questions

    1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF PATCH 
    lidocaine pain relief patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83559-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TARTARIC ACID (UNII: W4888I119H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83559-004-016 in 1 BOX; Type 0: Not a Combination Product04/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/07/2024
    Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Enokon Medical Instrument Co., Ltd.701730676manufacture(83559-004)