Label: LIDOCAINE 4% PATCH- lidocaine 4% patch

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

Drug Label Information

Updated October 12, 2023

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  • 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
    • 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 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 or 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

    Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

  • PRINCIPAL DISPLAY PANEL

    ​Questions or comments? 866-747-7365

    Lidocaine 4% Patch

    NDC 70512-014-30

    Qty: 30 Flex Patches

    (5 per resealable pouch) x 6

    Manufactured for:

    SOLA Pharmaceuticals

    Baton Rouge, LA 70810

    Carton

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 4% PATCH 
    lidocaine 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-014
    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
    FLAX SEED (UNII: 4110YT348C)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLE (White Flexible Patch) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-014-306 in 1 BOX05/24/2021
    15 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/24/2021
    Labeler - SOLA Pharmaceuticals (080121345)
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