Label: THERACARE PAIN RELIEF LIDOCAINE- 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

    Topical Anesthetic

  • Idications and Usage

    Uses: Temporaily relieves minor pains.

  • Warnings

    For external use only.

  • 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.

  • 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.

  • Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

  • 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 12 hours

    ■ discard patch afetr single use

    Children under 12 years of age: consult a physician.

  • Other Safety Information

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

  • Inactive Ingredients

    Crospovidone, dihydroxyaluminum aminoacetate, edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol,Propylparaben, 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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    THERACARE PAIN RELIEF LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-011
    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
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-011-055 in 1 CARTON10/01/2021
    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 DrugM01710/01/2021
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(71101-011)