Label: 4% LIDOCAINE MAXIMUM STRENGTH PAIN RELIEF- lidocaine patch

  • NDC Code(s): 85839-011-01
  • Packager: Shenzhen Finona Information Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 9, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Lidocaine 4%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    Use Temporarily relieves minor paln.

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use More than one patch on your body at a time On cut, initated orswollen skin On puncture wounds For more than one week without consultinga doctor lf you are allergic to any active or inactive ingredients lf pouch isdamaged or opened.

  • WHEN USING

    When using this product Use only as directed Read and follow alldirections and warings on this carton Do not allow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly orapply local heat (such as heating pads) to the area of use Dispose of usedpatch inmanner that always keeps product away from children and pets. Usedpatches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

  • STOP USE

    Stop use and consult a doctor if Condition worsens Redness is presentlrritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets.

  • DOSAGE & ADMINISTRATION


    Adults and children 12 years of age and over:
    Clean and dry affected area Carefully remove backing from patchstarting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch aftersingle use.Children under 12 years of age: consult a physician.

  • INACTIVE INGREDIENT

    Aluminum Glycinate
    Aluminum Hydroxide
    Cellulose Gum
    DMDM hydantoin
    Glycerin
    Polyacrylic Acid
    Polysorbate 80
    Propylene Glycol
    Ricinus Communis Seed Oil (castor)
    Silica
    Sodium Polyacrylate
    Tartaric Acid
    Titanium Dioxide
    Urea
    Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    4% LIDOCAINE MAXIMUM STRENGTH PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85839-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TARTARIC ACID (UNII: W4888I119H)  
    SILICA (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    CELLULOSE GUM (UNII: K679OBS311)  
    ALUMINUM GLYCINATE (UNII: 1K713C615K)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85839-011-0115 in 1 BOX09/09/2025
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/09/2025
    Labeler - Shenzhen Finona Information Technology Co., Ltd (511271543)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Finona Information Technology Co., Ltd511271543manufacture(85839-011)