83559-011

83559-011
SPL v1
SPL
SPL Set ID 3ecfa867-50f6-d98a-e063-6394a90aefa0
Route
TOPICAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Edetate Disodium Povidone, Unspecified Sodium Acrylate Tartaric Acid Aluminum Glycinate Ethylhexylglycerin Propylene Glycol Glycerin Phenoxyethanol Kaolin Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-15

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

For temporary relief of pain

Stop Use

Stop use and ask a doctor if

localized skin reaction occur,such as rash,itching,redness,irriation,pain swelling and blistering

conditions worsen

sympyoms persist for more than 7 days

sympyoms clear up and occur again within a few days

Warnings

For external use only

Ask Doctor

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

Children under age of 12: Consult a doctor

Directions

Directions

Adults and children above 12 years old and over

clean and dry the affected area.

remove film from patch and apply to the skin (see illustration)

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

remove patch from the skin after at most 8 hours of application.

Children under 12 years of age: consult a doctor

Do Not Use

Do not use

more than 1 patch at a time

on wounds or damaged skin

with a heating pad

if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly

Active Ingredient

Lidocaine 4%

Other Information

avoid storing product in direct sunlight

protect product from excessiver moisture

store at 20-25℃ (68-77℉)

Inactive Ingredients

Inactive Ingredients

Aluminum Glycinate,Edetate Disodium,Ethylhexylglycerin,Glycerin,Kaolin,Phenoxyethanol,Polyvinylpyrrolidone,Propylene,Sodium Carboxymethylcellulose,Sodium Polyacrylate, Tartaric Acid, Water

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed , get medical help or contact with Poison Control Center right away.


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical anesthetic

Stop Use

Stop use and ask a doctor if

localized skin reaction occur,such as rash,itching,redness,irriation,pain swelling and blistering

conditions worsen

sympyoms persist for more than 7 days

sympyoms clear up and occur again within a few days

Warnings

For external use only

Ask Doctor

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

Children under age of 12: Consult a doctor

Directions

Directions

Adults and children above 12 years old and over

clean and dry the affected area.

remove film from patch and apply to the skin (see illustration)

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

remove patch from the skin after at most 8 hours of application.

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

Do not use

more than 1 patch at a time

on wounds or damaged skin

with a heating pad

if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly

Active Ingredient

Lidocaine 4%

Other Information (Other information)

avoid storing product in direct sunlight

protect product from excessiver moisture

store at 20-25℃ (68-77℉)

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients

Aluminum Glycinate,Edetate Disodium,Ethylhexylglycerin,Glycerin,Kaolin,Phenoxyethanol,Polyvinylpyrrolidone,Propylene,Sodium Carboxymethylcellulose,Sodium Polyacrylate, Tartaric Acid, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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 with Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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