Label: LIDOCAINE 4% MAXIMUM OTC STRENGTH- lidocaine patch

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

Drug Label Information

Updated June 20, 2024

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  • Active Ingredient

    Lidocaine 4.0%

  • Purpose

    Topical anesthetic

  • Indications and Usage

    Temporarily relieves minor pain.

  • 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.

    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.

  • Directions

    Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not more than use one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

  • Other 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 or comments

    Call 1-866-326-1313

    This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercreme®.

    Distributed by:

    RUGBY® LABORATORIES

    Indianapolis, IN 46268

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    Made in China

    Questions or comments?

    Call 1-800-616-2471

    www.majorpharmaceuticals.com

  • Principal Display Panel

    LIDOCAINE PATCH 4%

    MAXIMUM OTC STRENGTH

    5 PATCHES

    4% bag label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4%  MAXIMUM OTC STRENGTH
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-7813(NDC:0536-1202)
    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:55154-7813-55 in 1 BAG06/20/2024
    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 DrugM01704/01/2019
    Labeler - Cardinal Health 107, LLC (118546603)
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