Label: THERA CARE 24HRS LIDOCAINE PATCH- lidocaine 4% patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 16, 2020

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  • 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 24 hours. Discard patch after single use. 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 800-222-1222

  • Other Safety Information

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

  • Inactive Ingredients

    Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil

  • Questions

    TOLL-FREE

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

    Manufactured For
    Veridian Healthcare, LLC
    Gurnee, IL 60031


    Made in China

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    THERA CARE 24HRS LIDOCAINE PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-916
    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
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)  
    HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-916-066 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 not finalpart34805/01/2018
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparsha Pharma USA, Inc.079365856manufacture(71101-916)
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