Label: LIDAFLEX- lidocaine patch

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

Drug Label Information

Updated May 20, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients:

    Lidocaine 4%

  • PURPOSE

    Purpose:

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses:

    For temporary relief of pain

  • WARNINGS

    Warnings:

    For external use only

  • DO NOT USE

    Do not use

    • More than 1 pathch 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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information:

    • Avoid storing product in direct sunlight
    • Protect product from exceessive moisture
  • INACTIVE INGREDIENT

    Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

  • PRINCIPAL DISPLAY PANEL

    ​Manufactured for:

    SOLA Pharmaceuticals

    655 Highlandia Dr. Ste B

    Baton Rouge, LA 70810

    For questions for comments call 866-747-7365

    LidaFlex Patch

    Topical Pain Patch

    For temporay pain relief

    NDC 70512-012-30

    Qty: 30 Flex Patches

    (5 per Resealable Pouch) x 6

    Carton

  • INGREDIENTS AND APPEARANCE
    LIDAFLEX 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-012
    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
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FLAX SEED (UNII: 4110YT348C)  
    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:70512-012-303 in 1 BOX01/27/2021
    11 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/27/2021
    Labeler - SOLA Pharmaceuticals (080121345)