Achelon Lidocaine 4% Patch; 1 Patch Per Pouch

Achelon Lidocaine 4% Patch; 1 Patch Per Pouch
SPL v1
SPL
SPL Set ID 31408e21-e58d-6db5-e063-6294a90aa4bc
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 Polyethylene Glycol 400 Acrylic Acid/ethylene Copolymer (600 Mpa.s) Isopropyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-26
Description

Lidocaine 4%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4%

Uses

For the temporary relief of pain.

Warnings

For external use only.

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

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
Other Information
  • store at 68 o - 77 o F (20 o - 25 o C)
Active Ingredients

Lidocaine 4%

Inactive Ingredients

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

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

Achelon Lidocaine 4%, One Patch in Indivdual Pouch

Structured Label Content

Uses

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 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

Do Not Use (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
Other Information (Other information)
  • store at 68 o - 77 o F (20 o - 25 o C)
Active Ingredients

Lidocaine 4%

Inactive Ingredients

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

When Using This Product (When using this product)
  • Use only as directed
  • Do not inject through any patch material
Stop Use Or Ask A Doctor If (Stop use or ask a doctor if)

If you develop a rash or skin irritation

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

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

Achelon Lidocaine 4%, One Patch in Indivdual Pouch

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:48.362811 · Updated: 2026-03-14T23:08:06.304944