Label: ACHELON LIDOCAINE PATCH- lidocaine patch 4% patch

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

Drug Label Information

Updated March 26, 2025

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  • Active Ingredient

    Lidocaine 4%

    Purpose

    Topical Analgesic

  • Inactive Ingredients

    Propylene Glycol 400

    Levulinic Acid

    Brij L4 LQ

    Isopropyl palmitate

  • Use

    For the temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    • on raw or blistered skin
    • on the eyes
    • if allergic to lidocaine or any ingredients in the patch
    • more than 4 daily
    • with a heating pad
  • When using this product

    • use only as directed
    • do not inject through any patch material
  • Stop use and ask a doctor if

    If you develop a rash or skin irritation

  • If pregnant or breastfeeding

    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.

  • Directions

    Adults and children 2 years of age or older:

    • Apply the patch to clean, dry skin 60 minutes prior to procedure
    • Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area
    • Follow usual needle procedure steps
    • Remove ring after procedure

    Children under 2 years of age:

    Consult a doctor prior to use

  • Box and Drug Facts Panel

    Box of 3 Patches

  • INGREDIENTS AND APPEARANCE
    ACHELON LIDOCAINE PATCH 
    lidocaine patch 4% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84209-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE7.54 mg  in 60.81 cm2
    Inactive Ingredients
    Ingredient NameStrength
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84209-400-033 in 1 BOX03/26/2025
    120.27 cm2 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/25/2025
    Labeler - Achelon, Inc (080928345)
    Registrant - Akron Coating & Adhesives (186569323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akron Coating & Adhesives186569323manufacture(84209-400)
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