84844-015

84844-015
SPL v1
SPL
SPL Set ID 273f93b6-8390-dfe6-e063-6394a90a728a
Route
topical
Published
Effective Date 2024-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
.alpha.-tocopherol acetate soybean lecithin .alpha.-ethyl-3,4-methylenedioxybenzylamine carbomer 934 propylene glycol water benzyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-19

Purpose

Local Anesthetic

Description

Lidocaine 4%


Medication Information

Warnings

For external use only.

Purpose

Local Anesthetic

Directions

■Before applying the numbing cream, thoroughly wash your hands and wear disposable tattoo gloves.

■Clean the area of the body receiving the tattoo. Dry completely.

■Apply a generous amount of numbing cream to the cleaned area and rub it in thoroughly in a circular motion for 30 to 60 seconds. Then, cover with plastic wrap.

■Leave the cream and wrap in place for 30 to 45 minutes. Wipe away the cream and thoroughly clean the area to prepare for a pain-free tattoo.

Other Information

Store between 15-30℃(59-86°F). Avoid freezing and excessive heat above 40℃(104°F).

Inactive Ingredients

Water ,Carbomer 934 ,Propylene Glycol,Soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Description

Lidocaine 4%

Principal Display Panel

Use

For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process.

Stop Use

section

■Stop use and seek medical attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms.■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. If symptoms do not subside completely within 7 days, seek medical help.

Ask Doctor

attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms.

■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician

Do Not Use

■In children less than 2 months of age on open skin wounds.

■Do not exceed the recommended daily dosage unless directed by a doctor.

When Using

■Avoid contact with eyes. If this happens, rinse thoroughly with water.

Active Ingredient

Lidocaine 4%

Keep Oot of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Purpose

Local Anesthetic

Directions

■Before applying the numbing cream, thoroughly wash your hands and wear disposable tattoo gloves.

■Clean the area of the body receiving the tattoo. Dry completely.

■Apply a generous amount of numbing cream to the cleaned area and rub it in thoroughly in a circular motion for 30 to 60 seconds. Then, cover with plastic wrap.

■Leave the cream and wrap in place for 30 to 45 minutes. Wipe away the cream and thoroughly clean the area to prepare for a pain-free tattoo.

Other Information (Other information)

Store between 15-30℃(59-86°F). Avoid freezing and excessive heat above 40℃(104°F).

Inactive Ingredients (Inactive ingredients)

Water ,Carbomer 934 ,Propylene Glycol,Soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

For temporary relief of local discomfort, itching, pain, soreness, or burning related to the tattoo process.

Stop Use

section

■Stop use and seek medical attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms.■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. If symptoms do not subside completely within 7 days, seek medical help.

Ask Doctor

attention if signs of an allergy occur, such as redness, irritation, swelling, pain, or other severe symptoms.

■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician

Do Not Use (Do not use)

■In children less than 2 months of age on open skin wounds.

■Do not exceed the recommended daily dosage unless directed by a doctor.

When Using

■Avoid contact with eyes. If this happens, rinse thoroughly with water.

Active Ingredient

Lidocaine 4%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach 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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