Label: PAIN RELIEF PATCH- lidocaine 4% patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 3, 2024

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For the temporary relief of minor pain.

  • Warnings

    For external use only.

    Do not use

    ■ If you are allergic to any active or inactive ingredients of this product ■ On wounds or damaged, irritated or sensitive skin
    ■ More than one patch on your body at a time or with other topical analgesics at the same time
    ■ For more than one week without consulting a doctor ■ With a heating pad ■ If pouch is damaged or opened.

    When using this product

    ■ Avoid contact with the eyes ■ Use only as directed ■ Read and follow all directions and warnings on this
    package ■ Do not bandage tightly or apply local heat to the area of use ■ Do not reuse patch ■ Keep this product away from pets and
    children. Used patches still contain the drug product that can produce serious adverse effect if a child or pet chews or ingests this
    patch

    Stop use and ask a doctor if

    ■ Condition worsens ■ Symptoms persist for more than seven days or clear up and occur again within a
    few days ■ Localized skin reactions such as rash, pain, itching, redness, irritation, swelling or blistering occur where the product was
    applied.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children and pets

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

  • Directions

    ■ Adults and children 12 years of age and over: Clean and dry affected area ■ Apply immediately upon removal from pouch ■ Peel off
    the first liner and apply exposed patch to affected area ■ Peel off second liner while applying the rest of patch ■ Remove patch after
    24 hours ■ Discard patch after single use.
    ■ Children under 12 years of age: Consult a doctor.

  • Other information

    Store in a clean, dry place away from direct sunlight. Store in original unopened pouch protected from moisture.

  • Inactive ingredients

    alicyclic hydrocarbon resin, mineral oil, polyester film, silicone-coated polyester film, styrene isoprene, styrene block copolymer.

  • Questions or comments?

    call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    Read directions and warning before use

    KEEP OUT OF REACH OF CHILDREN AND PETS

    Made in USA from Domestic and Imported Components

    Distributed by:
    Bionpharma Inc.
    Princeton, NJ
    08540

    L0000735
    R0623

  • Carton Label

    NDC 69452-409-04

    maximum strength

    a+ health TM

    pain relief
    lidocaine 4% patch
    topical analgesic

    • desensitizes aggravated nerves
    • odor free, thin & flexible
    • no-mess, single use application

    24 hours

    6 Patches

    2.91" x 2.17"

    carton

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-409
    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
    HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-409-046 in 1 CARTON10/04/2024
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/04/2024
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparsha Pharma USA, Inc.079365856manufacture(69452-409)
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