Tattoo Numbing Cream by Sainite Trading Shenzhen Co., Ltd.

Tattoo Numbing Cream by

Drug Labeling and Warnings

Tattoo Numbing Cream by is a Otc medication manufactured, distributed, or labeled by Sainite Trading Shenzhen Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TATTOO NUMBING CREAM- lidocaine cream 
Sainite Trading Shenzhen Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 5%

Topical anesthetic

For temporary relief of local discomfort, itching, pain, soreness.

For external use only. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. When using this product avoid contact with eyes. Flush with water if contact occurs. Do not apply over large areas of the body, particularly over raw surfaces or blistered areas.

Pregnant or breastfeeding, ask a health professional before use.

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), PropyleneGlycol, Tocopheryl Acetate, Carbomer, Menthol, Triethanolamine.

If swallowed, get medical help or contact a Poison Control Center right away.

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet
tissue or soft cloth before applying.
Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
Children under 12 years of age: consult a doctor.

Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product.

Apply externally up to 6 times per day.

Children under 12: Consult a Doctor.

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

NDC: 82929-012-08 10ml in 1 Tube

NDC: 82929-012-09 40ml in 1 Tube

NDC: 82929-012-10 60ml in 1 Tube

TATTOO NUMBING CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82929-012
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82929-012-08	10 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2022
2	NDC: 82929-012-09	40 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2022
3	NDC: 82929-012-10	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/12/2022

Labeler - Sainite Trading Shenzhen Co., Ltd. (418973870)

Revised: 8/2022

Document Id: e607c219-94da-503b-e053-2a95a90aad27

34390-5

Set id: e607c219-94d9-503b-e053-2a95a90aad27

Version: 1

Effective Time: 20220812