PRIMEROSE SNAIL HYDRO ESSENCE- niacinamide gel

PRIMEROSE SNAIL HYDRO ESSENCE by

Drug Labeling and Warnings

PRIMEROSE SNAIL HYDRO ESSENCE by is a Otc medication manufactured, distributed, or labeled by Royal Springs Cosmetics USA, LLC, Royal Springs Cosmetic Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Niacinamide (2%)

Purpose

skin protectant

Keep out of reach of children

- Do not swallow. In case of accidental ingestion, seek professional assistance.

Uses

Skin brightening and keep skin soft and smooth.

Warnings

For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on skin develops and lasts.
Store at room temperature

Directions

Apply adequate amount in the palm of hand, softly rub onto face and body until bubbles form. Massage gently.

Inactive ingredients

Snail Secretion Filtrate, Cyclohexasiloxane, Cyclopentasiloxane, Water, Glycerin, Sodium hyaluronate, Butylene Glycol, Phenyl trimethicone, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Dimethicone crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Macadamia integrifolia seed oil, Hydroxyethylcellulose, Methylparaben, Phenoxyethanol, Sodium EDTA, Fragrance

PRIMEROSE SNAIL HYDRO GEL ESSENCE

INGREDIENTS AND APPEARANCE

PRIMEROSE SNAIL HYDRO ESSENCE 
niacinamide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69888-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.02   in 120 mL

Inactive Ingredients
Ingredient Name	Strength
SNAIL, UNSPECIFIED (UNII: 2VIO5GL90I)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POMEGRANATE (UNII: 56687D1Z4D)
ASIAN GINSENG (UNII: CUQ3A77YXI)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)
MACADAMIA OIL (UNII: 515610SU8C)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69888-104-02	1 in 1 PACKAGE	02/13/2018
1	NDC: 69888-104-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/13/2018

Labeler - Royal Springs Cosmetics USA, LLC (079837692)

Registrant - Royal Springs Cosmetics USA, LLC (079837692)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Springs Cosmetics USA, LLC		079837692	relabel(69888-104)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Springs Cosmetic Co.,Ltd.		689514344	manufacture(69888-104)