ACHELON LIDOCAINE PATCH- lidocaine patch 4% patch

Achelon Lidocaine Patch by

Drug Labeling and Warnings

Achelon Lidocaine Patch by is a Otc medication manufactured, distributed, or labeled by Achelon, Inc, Akron Coating & Adhesives. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only.

Do not use

Do not use

• on raw or blistered skin
• on the eyes
• if alergic to lidocaine or any ingredient 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 or ask a doctor if

If you develop a rash or skin irritation

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

Directions

Adults and children 2 years of age or older:

• Apply the patch to clean dry skin 60 minutes before 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

Other information

• store at 68 o - 77 o F (20 o - 25 o C)

Inactive Ingredients

Acrylic adhesive, Polyethylene film, Mylar release liner, Polyethylene Glycol, Levulinic acid, BrijL4LQ, Isopropyl Palmitate

Achelon Lidocaine 4%, One Patch in Indivdual Pouch

INGREDIENTS AND APPEARANCE

ACHELON LIDOCAINE PATCH 
lidocaine patch 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84209-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	7.54 mg  in 60.81 cm2

Inactive Ingredients
Ingredient Name	Strength
LEVULINIC ACID (UNII: RYX5QG61EI)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84209-400-01	60.81 cm2 in 1 POUCH; Type 0: Not a Combination Product	03/26/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/26/2025

Labeler - Achelon, Inc (080928345)

Registrant - Akron Coating & Adhesives (186566932)

Establishment
Name	Address	ID/FEI	Business Operations
Akron Coating & Adhesives		186569323	manufacture(84209-400)