Label: PAIN RELIEVING PATCH- lidocaine 4% patch

  • NDC Code(s): 84273-001-01
  • Packager: Hunan En Pu Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 26, 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

    For the temporary relief of pain

  • WARNINGS

    For external use only

  • DO NOT USE

    more than 1 patch on your body at a time
    on cut,irritated,or swollen skin
    on puncture wounds
    for more than one week without consulting a doctor

  • WHEN USING

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

  • STOP USE

    condition worsens
    symptoms persist for more than 7 days or clear up and occur again within a few days
    redness or irritation develops
    you experience signs of skin injury, such as pain, sweling, or blistering where
    the product was applied

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:
    Wash and dry the affected area.
    Peel off the backing film from one side of the patch carefully
    Apply the exposed portion of the patch to the affected area.
    Gently press the patch with your hand to fit the affected area completely.
    Do not exercise vigorously during use to prevent the patch from falling off.
    Use only 1 patch for a maximum of 8 hours.
    Children under 12 years of age: Ask a doctor before use

  • STORAGE AND HANDLING

    store at room temperature 15°-30C (59-86F).

  • INACTIVE INGREDIENT

    aluminum glycinate
    glycerin
    methyl acrylate
    polyacrylic acid
    polysorbate 80
    propylene glycol
    sodium polyacrylate
    tartaric acid
    poval
    alcohol

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84273-001
    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
    TARTARIC ACID (UNII: W4888I119H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYVINYL ALCOHOL (18000 MW) (UNII: BRY146A46V)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84273-001-015 in 1 BOX04/22/2024
    11 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/22/2024
    Labeler - Hunan En Pu Pharmaceutical Co., Ltd. (842391330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hunan En Pu Pharmaceutical Co., Ltd.842391330manufacture(84273-001)