83559-007

83559-007
SPL v1
SPL
SPL Set ID 2c593420-5788-3422-e063-6394a90a1890
Route
TOPICAL
Published
Effective Date 2025-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-23

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 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

Warnings

For external use only

Ask Doctor

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

Children under 12 years of age: consult a doctor

Directions

Directions

Adults and children 12 years of age and over

clean and dry 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

Other information

avoid storing product in direct sunlight

protect product from excessive moisture

store at 20-25°C(68-77°F)

Inactive Ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, 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 a 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 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

Warnings

For external use only

Ask Doctor

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

Children under 12 years of age: consult a doctor

Directions

Directions

Adults and children 12 years of age and over

clean and dry 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)

Other information

avoid storing product in direct sunlight

protect product from excessive moisture

store at 20-25°C(68-77°F)

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, 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 a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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