MedPath

BaoDao TATTOO NUMBING

84010-114

Approved
Approval ID

352571b6-c8f1-3d4c-e063-6394a90a83ab

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine 4% TATTOO NUMBING

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-114
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine 4% TATTOO NUMBING
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (13)

LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 mL
Code: 98PI200987
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
COCO GLUCOSIDEInactive
Code: ICS790225B
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2025

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

Active Ingredient

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

Purpose

Local Anesthetic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/15/2025

Do not use

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

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

If 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, irritation, swelling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medicahelp.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/15/2025

When Using

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/15/2025

Stop Use

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/15/2025

Ask Doctor

Stop use and seek medical attention if signs of an allergy occur, such as redness, irritation, swelling ,pain,or other severe symptoms.If symptoms do not subside completely within 7 days, seek medicalhelp.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/15/2025

Keep Out Of Reach Of Children

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

Directions

Clean the residue from the tattooed area before spraying.Then, spray 2-3 times repeatedly to ensure full skin absorption.

After approximately 10-20 seconds, the skin will start to feel numb. For a longer-lasting numbing effect, consider spraying multiple times and extending the waiting period.

During the tattooing process, spray a moderate amount of this product every 3-5 minutes, regardless of whether experiencing pain, to achieve a pain-free tattooing experience throughout.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/15/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2025

Inactive ingredients

Water,Aloe Vera Leaf,Cetostearyl Alcohol,CoconutOil,Sunfower Oil,Lactic Acid,Benzoic Acid,Citric Acid Monohydrate,Coco Glucoside,Phenoxyethanol,Shea Butter,Xanthan Gum.

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BaoDao TATTOO NUMBING - FDA Drug Approval Details