Label: LIDOCAINE PAIN RELIEVING GEL-PATCH- lidocaine 4% patch

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

Drug Label Information

Updated March 1, 2024

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • INDICATIONS & USAGE

    For temporary relief of pain

  • Warnings

    For External Use Only

  • Stop use and ask a doctor

    • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Condition worsens
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Do Not Use

    • More than 1 patch at a time
    • On wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product
  • If Pregnant or Breast-Feeding

    Ask a health professional before use

  • When Using this product

    • Use only as directed
    • Avoid contact with eyes, mucous membranes or rashes
    • Do not bandage tightly
  • Directions

    Adult and children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from teh skin after at most 8-hour application
    • Children under 12 years of age. Consult a doctor
  • Other information

    • Store at controlled room temperature 68º-77ºF (20º-25ºC)
    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture

  • Inactive Ingredients

    Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

  • Questions or Comments

    Call (347) 378-8990

    M-F 9-5 or by email info@nobleotc.com

  • Distributed By

    Manufactured For

    Noble OTC LLC

    Upper Saddle River, NJ 07458

    www.nobleotc.com

  • PRINCIPAL DISPLAY PANEL

    Noble Lidocaine patch CDER

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEVING GEL-PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-201
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    KAOLIN (UNII: 24H4NWX5CO)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-201-055 in 1 BOX02/28/2024
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/28/2024
    Labeler - Noble OTC LLC (041836435)
    Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)
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