SPL v2
SPL
SPL Set ID 1de1169c-e6dd-486f-e063-6394a90a3b59
Route
TOPICAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Alpha-tocopherol Acetate Benzyl Alcohol Carbomer 934 Water Soybean Lecithin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-24

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Use

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

Package

Stop Use

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

Avoid contact with eyes. lf this happens, rinse thoroughly with water.

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

Stop use and seek medical attention if signs of an allergy occur, such as redness,iritation, sweling, pain, or other severe symptoms. fsymptoms do not subside completely within 7 days, seek medica help.

Warnings

For external use only.

Ask Doctor

Stop use and sek meditcal attention if signs of an alerqy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.

Directions

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

Clean the area of the body receivina the tattoo,Dry completely.

Apply a generous amount of numbing cream to the cleaned area and rub it inthoroughly in a circlar motion for30 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 exceed the recommended daily dosage unless directed by a doctor

Active Ingredient

Lidocaine 5%

Other Information

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

Inactive Ingredients

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

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

Package

Purpose

Local Anesthetic

Stop Use

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

Avoid contact with eyes. lf this happens, rinse thoroughly with water.

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

Stop use and seek medical attention if signs of an allergy occur, such as redness,iritation, sweling, pain, or other severe symptoms. fsymptoms do not subside completely within 7 days, seek medica help.

Warnings

For external use only.

Ask Doctor

Stop use and sek meditcal attention if signs of an alerqy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.

Directions

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

Clean the area of the body receivina the tattoo,Dry completely.

Apply a generous amount of numbing cream to the cleaned area and rub it inthoroughly in a circlar motion for30 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)

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

Active Ingredient

Lidocaine 5%

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,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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