PRINUMB TATTOO NUMBING CREAM- tattoo numbing cream cream

Prinumb Tattoo Numbing Cream by

Drug Labeling and Warnings

Prinumb Tattoo Numbing Cream by is a Otc medication manufactured, distributed, or labeled by Shijiazhuang Auro Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Use

For temporarily relieves pain and itching associated with minor burns, minor cuts or skin irritations

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 persons can develop allergic reactions to ingredients in this product.
Do not put this product into the rectum by using fingers or any medical device or applicator.

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.

Ask Doctor

discomfort persists for 7 days.

Keep Oot Of Reach Of Children

Avoid contact with the eyes.If swallowed,seek medical attention immediately.

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

Store at room temperature and out of direct sunlight or heat.

Inactive ingredients

.Alpha.-Tocopherol Acetate
Carbomer 940
Chrysanthemum Extract
Glycerol，
Lecithin, Soybean
Portulaca Oleracea Extract
Prilocaine
Propylene Glycol
Sodium Hyaluronate
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRINUMB TATTOO NUMBING CREAM 
tattoo numbing cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84555-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHRYSANTHEMUM INDICUM WHOLE (UNII: O9ECF2PL1F)
PRILOCAINE (UNII: 046O35D44R)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
PURSLANE (UNII: M6S840WXG5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84555-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2024
2	NDC: 84555-001-02	100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/17/2024
3	NDC: 84555-001-03	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2024
4	NDC: 84555-001-04	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2024
5	NDC: 84555-001-05	30 mL in 1 TUBE; Type 0: Not a Combination Product	07/17/2024
6	NDC: 84555-001-06	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/17/2024

Labeler - Shijiazhuang Auro Technology Co., Ltd. (406846461)

Establishment
Name	Address	ID/FEI	Business Operations
Shijiazhuang Auro Technology Co., Ltd.		406846461	manufacture(84555-001)