PRIMEROSE SNAIL HYDRO ESSENCE- niacinamide gel 
Royal Springs Cosmetics USA, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRIMEROSE SNAIL HYDRO GEL ESSENCE

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

hydro gel

PRIMEROSE SNAIL HYDRO ESSENCE 
niacinamide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 120 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69888-104-021 in 1 PACKAGE02/13/2018
1NDC:69888-104-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/13/2018
Labeler - Royal Springs Cosmetics USA, LLC (079837692)
Registrant - Royal Springs Cosmetics USA, LLC (079837692)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetics USA, LLC079837692relabel(69888-104)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetic Co.,Ltd.689514344manufacture(69888-104)

Revised: 1/2019
Document Id: 7f898b2d-711c-94d7-e053-2991aa0adc48
Set id: 24e319a9-cbb4-4171-8539-2570fdb43a98
Version: 7
Effective Time: 20190115
 
Royal Springs Cosmetics USA, LLC