SAMNYTE TATTOO NUMBING CREAM- lidocaine emulsion

SAMNYTE Tattoo Numbing Cream by

Drug Labeling and Warnings

SAMNYTE 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]

Active Ingredients

Lidocaine 5%

Purpose

Topical Anesthetic

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Warnings

For external use only

Do not this product

Pregnant or breastfeeding, ask a health professional before use.

When using this product

Do not exceed the recommended daily dosage unless directed by a doctor
Do not put into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use

Keep out of reach of children

In case of accidental ingestion, seek madical attention immediately

Directions

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

Other Informatiom

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

Inactive Ingredients

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

30ml / 1.06 Fl.Oz

40ml / 1.41 Fl.Oz

60ml / 2.12 Fl.Oz

INGREDIENTS AND APPEARANCE

SAMNYTE TATTOO NUMBING CREAM 
lidocaine emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82929-010
Route of Administration	CUTANEOUS

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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MENTHOL (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82929-010-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2024
2	NDC: 82929-010-02	40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2024
3	NDC: 82929-010-03	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/24/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Sainite Trading Shenzhen Co., Ltd.		418973870	label(82929-010) , manufacture(82929-010)