ACHELON LIDOCAINE PATCH- lidocaine patch 4% patch 
Achelon, Inc

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Achelon Lidocaine 4% Patch

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

When using this product

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:

Children under 2 years of age:

Consult a doctor prior to use

Box and Drug Facts Panel

Box of 3 Patches

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)

Revised: 3/2025
Document Id: 3143c8a1-9d16-9eb6-e063-6394a90ab16b
Set id: 3143bb72-2969-d66e-e063-6294a90a4604
Version: 1
Effective Time: 20250326
 
Achelon, Inc