Lidocaine 4% Topical Patch

Lidocaine 4% Topical Patch
SPL v2
SPL
SPL Set ID 3763b75d-0919-cfe9-e063-6394a90a9c6f
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Flax Seed Polysorbate 80 Acrylic Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-11

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves pain and itching associated with: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
Section 50567-7

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes, or rashes
  • Do not bandage tightly
Section 50570-1

Do not use:

  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Section 51945-4

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

For external use only

Directions

Adults and children 12 years of age or over:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain
  • Apply immediately after the removal of the protective envelope
  • Wash hands with soap and water after handling the patches
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years of age:Ask a physician

Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Active Ingredients

Lidocaine 4%


Structured Label Content

Uses

Temporarily relieves pain and itching associated with: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes, or rashes
  • Do not bandage tightly
Section 50570-1 (50570-1)

Do not use:

  • More than 1 patch at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age or over:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain
  • Apply immediately after the removal of the protective envelope
  • Wash hands with soap and water after handling the patches
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years of age:Ask a physician

Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Active Ingredients

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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