SPL v1
SPL
SPL Set ID 44121d40-86e1-0df6-e063-6294a90aedaf
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Dmdm Hydantoin Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Titanium Dioxide Polyacrylic Acid (800000 Mw) Glycerin Edetic Acid Sodium Polyacrylate (8000 Mw) Tartaric Acid Laurocapram Dihydroxyaluminum Aminoacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

​Lidocaine 4 % w/w

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

​Lidocaine 4 % w/w

Use

For temporary relief of pain.

Section 51945-4

Warnings

For external use only.

Directions

Adults and children 12 years of age and older: apply to affected area; changes patch 1 to 2 daily.

Children under 12 years of age: consult a doctor. Supervise children when they use this product

How to apply:

Clean and dry affected area

Remove film from patch and apply directly to area of pain

Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.

Remove patch from the skin. Do not leave on skin for more than a total of 8 hours per day.

Children under 12 years of age: do not use, consult a doctor.

Do Not Use

More than 1 patch at a time

If you are allergic to any ingredients of this product

In large quantities, particularly over raw surface or blistered areas.

Other Information

Store between 15-30℃(59-86℉)

Protect product from excessive moisture

Avoid storing product in direct sunlight

Active Ingredient(s)

​Lidocaine 4 % w/w

Inactive Ingredients

Acyclmide/Sodium Acryloyldimethyltaurate copolyme, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid, Glycerin, Polyacrylic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product:

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water.

Do not apply to wounds, damaged or irritation skin.

Do not use with a heating pad such as electric heating pad, as this may result in excessive skin irritation or skin burn.

If Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:

Condition worsens

Severe skin irritation occurs

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days


Structured Label Content

Use

For temporary relief of pain.

Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older: apply to affected area; changes patch 1 to 2 daily.

Children under 12 years of age: consult a doctor. Supervise children when they use this product

How to apply:

Clean and dry affected area

Remove film from patch and apply directly to area of pain

Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.

Remove patch from the skin. Do not leave on skin for more than a total of 8 hours per day.

Children under 12 years of age: do not use, consult a doctor.

Do Not Use (Do not use)

More than 1 patch at a time

If you are allergic to any ingredients of this product

In large quantities, particularly over raw surface or blistered areas.

Other Information (Other information)

Store between 15-30℃(59-86℉)

Protect product from excessive moisture

Avoid storing product in direct sunlight

Active Ingredient(s)

​Lidocaine 4 % w/w

Inactive Ingredients (Inactive ingredients)

Acyclmide/Sodium Acryloyldimethyltaurate copolyme, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid, Glycerin, Polyacrylic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product: (When using this product:)

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water.

Do not apply to wounds, damaged or irritation skin.

Do not use with a heating pad such as electric heating pad, as this may result in excessive skin irritation or skin burn.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

If pregnant or breastfeeding, ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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

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

Condition worsens

Severe skin irritation occurs

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days


Advanced Ingredient Data


Raw Label Data

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