Label: LIDOCAINE 4% PATCH- lidocaine 4% patch

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

Drug Label Information

Updated March 8, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Lidocaine

  • 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
    • if you are allergic to any ingredients of this product
  • WHEN USING

    When using this product

    • use only as directed
    • avoid contact with the 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 care 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
  • Other Ingredients

    Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

  • PRINCIPAL DISPLAY PANEL

    Questions or comments? 866-747-7365

    Lidocaine 4% Patch

    NDC 70512-812-30

    Qty: 30 patches

    Manufactured for:

    SOLA Pharmaceuticals

    Baton Rouge, LA 70810

    Made in China

    box

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TARTARIC ACID (UNII: W4888I119H)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-812-3030 in 1 BOX10/12/2023
    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 DrugM01710/12/2023
    Labeler - SOLA Pharmaceuticals (080121345)