83559-004

83559-004
SPL v1
SPL
SPL Set ID 1592a40a-a647-34bd-e063-6394a90a0a10
Route
TOPICAL
Published
Effective Date 2024-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-07

Description

Lidocaine 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

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

Questions

1-800-910-6874

Ask Doctor

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

Children under 12 years of age: consult a doctor

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

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 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 analgesic

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

Questions

1-800-910-6874

Ask Doctor

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

Children under 12 years of age: consult a doctor

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

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 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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