Label: PAIN RELIEF PATCHES- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

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

  • Active Ingredients

    Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

  • Purpose

    Temporarily relieves minor pain.

  • Dosage and Administration

    Directions Adults and children over 12 years:

    ■ clean and dry affected area

    ■ carefully remove backing from patch starting at corner

    ■ apply sticky side of patch to affected area

    ■ use one patch for up to 8 hours. Children under 12 years of age: consult a physician.

  • Warnings

    For external use only.

  • Idications and Usage

    Uses: Temporaily relieves minor pains.

  • 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 use at the same time as other topical analgesics

    ■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

    ■ do not microwave

    ■ 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.

  • Stop use and consult a doctor

    ■ 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • Do not Use

    ■ more than one 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

    ■ if you are allergic to any active or inactive ingredients

    ■ if pouch is damaged or opened.

  • Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other Safety Information

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

  • Inactive Ingredients

    Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,
    Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions

    TOLL-FREE

    Customer Care Help Line
    866-326-1313
    Mon–Fri 8:30 am–4:30 pm CST

    DIST. BY
    HARRIS TEETER, LLC
    MATTHEWS, NC 28105


    Made in China

  • PRINCIPAL DISPLAY PANEL

    Lidocaine  Patch
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PATCHES 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-911
    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
    ALUMINUM (UNII: CPD4NFA903)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72036-911-055 in 1 CARTON05/01/2018
    19 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2018
    Labeler - Harris Teeter (047279351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(72036-911)