Label: ASPERFLEX- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 12, 2023

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  • 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

    aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide urea, poval, alcohol, 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

    Carton

  • 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)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    ALCOHOL (UNII: 3K9958V90M)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/04/2021
    Labeler - Akron Pharma Inc. (067878881)
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