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

Description

Lidocaine 4%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 4%

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.

Warnings

For external use only.

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

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.

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%

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.

Principal Display Panel

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

Use

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

Purpose

Local Anesthetic

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.

Warnings

For external use only.

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

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.

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%

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)

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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