AOBBIY Tattoo Numbing Cream by Shenzhen Situya Trading Co., Ltd. 82739-014 Complete

Drug Details [pdf]

AOBBIY TATTOO NUMBING CREAM- tattoo numbing cream cream
Shenzhen Situya Trading Co., Ltd.

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82739-014 Complete

Active Ingredient

LIDOCAINE 5%

Purpose

Local Anesthetic

Use

temporarily relieves local and anorectal discomfort associated with the anorectal disorder or swelling.

Warnings

For external use only.

Do not use

pregnant or breastfeeding, ask your doctor before use.
in case of accidental overdose, seek immediate medical help or contact the Poison Control Center.
seal is broken or missing.

When Using

do not exceed the recommended daily dosage unless directed by a doctor. Certain sensitive individuals may have an allergic reaction to some of the ingredients of this product.
do not put this cream into the rectum using your fingers, applicators, or any medical devices.

Stop Use

the symptom being treated does not improve, or if redness, irritation, swelling, pain, or other symptoms appear or worsen. Seek medical help right away.

Keep Oot Of Reach Of Children

In case of accidental ingestion, seek medical help right away.

Directions

Apply up to 3 times a day.
Children (under 12 years of age): consult a doctor.
Adults: before applying this product, clean the affected area with mild soap and warm water and rinse thoroughly. Pat dry the area with a soft cloth or tissue.

Other information

Keep away from direct sunlight or heat.
Store at room temperature 59°-86°F (15°-30°C).

Inactive ingredients

Aqua, Propylene Glycol, Carbomer 934, Lecithin (Soybean), Tocopheryl Acetate, Benzyl Alcohol.

Notice

Due to the difference in temperature and skin type, the numbness effect duration will differ. Testing in a small area first is recommended to ensure the best numbness effect.

Correct Use Steps Before Tattooing

1. Clean your hands and the treatment area with soft soap and warm water, rinse thoroughly, then gently pat dry.
2. Apply a thick layer of the numbing cream onto
the treatment area.
3. Wrap tightly with plastic wrap and wait 45-60 minutes for the numbness to peak. (The peak lasts up to 6 hours.) 4. Wipe away the residue with a soft cloth or tissue.
5. Begin the procedure.

PRINCIPAL DISPLAY PANEL

AOBBIY TATTOO NUMBING CREAM
tattoo numbing cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82739-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 934 (UNII: Z135WT9208)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 82739-014-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/04/2023
2	NDC: 82739-014-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/04/2023
3	NDC: 82739-014-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/04/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	07/04/2023	12/23/2024

Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Situya Trading Co., Ltd.		706154255	label(82739-014) , manufacture(82739-014)

Revised: 12/2024

Document Id: 29eae75d-93db-7a5a-e063-6394a90ac0c0

Set id: ffb5226b-b42d-bf4f-e053-6294a90a4b68

Version: 2

Effective Time: 20241223