Label: PAIN RELIVEING PATCH- lidocaine 4% patch

  • NDC Code(s): 62379-201-01, 62379-201-02, 62379-201-03
  • Packager: simple diagnostics
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 26, 2024

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

  • Drug Facts

    LIDOCAINE PATCH 4%

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • USE

    For the temporary relief of pain

  • Warnings

    For external use only

    Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
    for more than one week without consulting a doctor

  • When using this product

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

  • DO NOT USE:

    • More than 1 patch at a time
    • On wounds or damaged skin
    • For more than one week without consulting a doctor
    • If you are allergic to any ingredients of this product
  • STOP USE AND ASK A DOCTOR IF:

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Condition worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • 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(1-800-222-1222).

  • Directions

    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.

  • QUESTIONS OR COMMENTS:

    • Customerservice@simplediagnostics.com
    • 877-342-2385
  • Other information

    • Store at room temperature 15°-30°C (59°-86°F)
    • Store in a cool dry place away from direct sunlight
  • Inactive ingredient

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

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL:

    Pack of 30 PouchesPack of 5 PouchesPouch

  • INGREDIENTS AND APPEARANCE
    PAIN RELIVEING PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62379-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62379-201-0330 in 1 CASE06/01/2023
    1NDC:62379-201-025 in 1 BOX
    1NDC:62379-201-011 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2023
    Labeler - simple diagnostics (004135503)