Label: ASPERFLEX- lidocaine patch

  • NDC Code(s): 71399-4456-3, 71399-4456-5
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 10, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    for the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • on puncture wounds, cuts, irritated or swollen skin
    • more than 1 patch on your body at a time or with other topical analgesics at the same time
    • with a heating pad or apply local heat to the area of use

    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 bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • 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 ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • redness or irritation develops
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breast-feeding,

    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 right away (1-800-222-1222).

  • Directions

    adults and children over 12 years:

    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch at a time and not more than 3 to 4 times daily

    children 12 years or younger: consult a doctor

  • Other Information

    store at room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

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

  • Questions or Comments? 

    Call toll-free 1-877-255-6999.

    Manufactured for:

    Akron Pharma Inc.,

    Fairfield, NJ-07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    5

    30

  • INGREDIENTS AND APPEARANCE
    ASPERFLEX 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-4456
    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
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-4456-55 in 1 CARTON11/04/2021
    10.246 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:71399-4456-330 in 1 CARTON02/06/2025
    20.246 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/04/2021
    Labeler - Akron Pharma Inc. (067878881)