Lidocaine Patch

Lidocaine Patch
SPL v1
SPL
SPL Set ID 2310b6ae-cacf-4b29-9b03-7f42849dfc18
Route
TOPICAL
Published
Effective Date 2025-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Polysorbate 80 Tartaric Acid Dihydroxyaluminum Aminoacetate Methylparaben Peppermint Oil Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-22

Description

LIDOCAINE – Lidocaine 4% Patch Alexso, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine 4% Patch Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

LIDOCAINE – Lidocaine 4% Patch Alexso, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Lidocaine 4% Patch Drug Facts

Uses

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

Section 42229-5

LIDOCAINE – Lidocaine 4% Patch

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% Patch



Drug Facts

Warnings

For external use only.

Read all warnings and directions before use.

Directions

Adults and children 12 years of age and older:

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 removal from 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: Ask a physician

Do Not Use

• More than one patch at a time

• On wounds or damaged skin

• With a heating pad

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

Active Ingredient

Lidocaine 4%

Other Information

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

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

Principal Display Panel

Lidocaine 4% Patch

NDC 68788-4029-1

10 Patches per Box

Alexso, Inc

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product

• Use only as directed. 

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop Use and Ask A Physician:

• If pregnant or breast feeding

• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

Section 42229-5 (42229-5)

LIDOCAINE – Lidocaine 4% Patch

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Lidocaine 4% Patch



Drug Facts

Purpose

External analgesic

Warnings

For external use only.

Read all warnings and directions before use.

Directions

Adults and children 12 years of age and older:

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 removal from 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: Ask a physician

Do Not Use (Do not use)

• More than one patch at a time

• On wounds or damaged skin

• With a heating pad

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

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

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Lidocaine 4% Patch

NDC 68788-4029-1

10 Patches per Box

Alexso, Inc

Relabeled By: Preferred Pharmaceuticals Inc.

When Using This Product (When using this product)

• Use only as directed. 

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop Use and Ask A Physician: (Stop use and ask a physician:)

• If pregnant or breast feeding

• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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 immediately.


Advanced Ingredient Data


Raw Label Data

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