achelon lidocaine 4% patch

SPL v1

SPL

SPL Set ID 3143bb72-2969-d66e-e063-6294a90a4604

Route

topical

Published

Effective Date 2025-03-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

lidocaine (7.54 mg)

Inactive Ingredients

levulinic acid isopropyl palmitate polyethylene glycol 400 acrylic acid/ethylene copolymer (600 mpa.s)

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-03-25

Purpose

Topical Analgesic

Description

Lidocaine 4%

Medication Information

Warnings

For external use only

Purpose

Topical Analgesic

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

Inactive Ingredients

Propylene Glycol 400

Levulinic Acid

Brij L4 LQ

Isopropyl palmitate

Description

Lidocaine 4%

Use

For the temporary relief of pain

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

Active Ingredient

Lidocaine 4%

When Using This Product

use only as directed
do not inject through any patch material

Box and Drug Facts Panel

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If

If you develop a rash or skin irritation

Keep Out of Reach of Children and Pets

if swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Purpose

Topical Analgesic

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

Inactive Ingredients

Propylene Glycol 400

Levulinic Acid

Brij L4 LQ

Isopropyl palmitate

Use

For the temporary relief of pain

do Not Use (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

Active Ingredient

Lidocaine 4%

When Using This Product (When using this product)

use only as directed
do not inject through any patch material

Box and Drug Facts Panel

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

If you develop a rash or skin irritation

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

if swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "LEVULINIC ACID", "unii": "RYX5QG61EI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL PALMITATE", "unii": "8CRQ2TH63M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)", "unii": "1PEZ3NLY6I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "7.54", "strengthDenominator": "60.81", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "cm2"}]

Raw Label Data

All Sections (JSON)

{"Use": "For the temporary relief of pain", "Purpose": "Topical Analgesic", "Warnings": "For external use only", "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", "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", "Active Ingredient": "Lidocaine 4%", "Inactive Ingredients": "Propylene Glycol 400 Levulinic Acid Brij L4 LQ Isopropyl palmitate", "When using this product": "use only as directed do not inject through any patch material", "If pregnant or breastfeeding": "ask a health professional before use.", "Stop use and ask a doctor if": "If you develop a rash or skin irritation", "Keep out of reach of children and pets": "if swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.365544 · Updated: 2026-03-14T23:08:06.304944