Label: LIDOCORE- 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 May 24, 2023

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  • Drug Facts

  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses:

    For the temporary relief of pain

  • Warnings:

    For external use only

  • DO NOT USE

    Do not use

    • more than 1 patch at a time
    • on wounds or damaged skin
    • with a heating pad
    • or if you are allergic to any ingredients of this product
  • WHEN USING

    When using this product

    • use only as directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and children 12 years of age and over:

    • Clean and dry the affected area
    • Open pouch and remove one patch
    • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
    • Reseal pouch containing unused patches after each use
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

  • Other information:

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture

  • INACTIVE INGREDIENT

    Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

  • QUESTIONS

    ​Questions or comments? 833.711.8833

    • info@ionpharmausa.com
  • PRINCIPAL DISPLAY PANEL

    NDC 82944-100-10

    LIDOCORE
    Lidocaine 4% Topical Anesthetic

    TOPICAL PAIN PATCH
    For Temporary Pain Relief

    Flexible Patch Innovation

    Soothing and Effective
    Long Lasting Relief

    MADE IN USA

    Qty: 10 Flexible Patches

    (5 per Resealable Pouch) x2

    3 x 5 (7.62cm x 12.7cm)

    ION PHARMA

    Lidocore

  • INGREDIENTS AND APPEARANCE
    LIDOCORE 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82944-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82944-100-1010 in 1 BOX06/01/2023
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2023
    Labeler - Ion Pharma, LLC (118739596)
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