Label: LIDOCAINE PATCH- lidocaine patch

  • NDC Code(s): 84023-601-01
  • Packager: Shenzhen Yangan Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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

  • SPL UNCLASSIFIED SECTION

    Lidocaine Patch

  • ACTIVE INGREDIENT

    Lidocaine 4%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain.

  • WARNINGS

    For external use only

  • DO NOT USE

    More than one patch on your body at a time
    On cut, initated or swollen skin
    On puncture wounds
    For more than one week without consulting a doctor
    lf you are allergic to any active or inactive ingredients lf pouch is damaged 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, Used patches 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 present
    Irritation 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 patchto affected area. Use one patch for up to 12 hours. Discard patch aftersingleuse.Children under 12 years of age: consult a physician.

  • STORAGE AND HANDLING

    Store in a clean, dry place outside of direct sunlight. Protect product form
    excessive moisture.

  • INACTIVE INGREDIENT

  • 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
    LIDOCAINE PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84023-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    UREA (UNII: 8W8T17847W)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84023-601-0120 in 1 BOX03/18/2024
    12 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/18/2024
    Labeler - Shenzhen Yangan Technology Co., Ltd. (419283765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Yangan Technology Co., Ltd.419283765manufacture(84023-601)