83559-006

83559-006
SPL v1
SPL
SPL Set ID 26769590-cd50-1b01-e063-6394a90a445c
Route
TOPICAL
Published
Effective Date 2024-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-09

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

For temporary relief of pain

Stop Use

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

Directions

Adults and children 12 years of age and over:

Clean and dry affected area

Remove film from patch and apply to the skin

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

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

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 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 Oot 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

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

Directions

Adults and children 12 years of age and over:

Clean and dry affected area

Remove film from patch and apply to the skin

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

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 (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 Oot of Reach of Children (Keep Oot 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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