PRIMEROSE EGF- niacinamide, dimethicone, adenosine cream 
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 EGF REPAIRING CREAM

Active ingredients

Niacinamide (2%)
Dimethicone (1.5%)
Adenosine (0.04%)

Purpose

skin protectant

Keep out of reach of children

Keep out of reach of children
- Do not swallow. In case of accidental ingestion, seek professional assistance.

Uses

Skin brightening and wrinkle care. 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 neck. For dry skin, use Repairing Cream after using Essence Skin.

Inactive ingredients

Water, Glycerin, Sodium hyaluronate, Butylene Glycol, Neopentyl Glycol Diheptanoate, Cetearyl alcohol, Dimethicone/vinyl dimethicone crosspolymer, Cyclohexasiloxane, Cyclopentasiloxane, Polyacrylate-13, Human oligopeptide-1, Polyglyceryl-3 Methylglucose Distearate, PEG-100 stearate, Glyceryl stearate, Cetyl ethylhexanoate, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate-60, Macadamia integrifolia seed oil, Arginine, Phenoxyethanol, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Caramel, Beta-glucan, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Pyridoxyne hydrochloride, Maltodextrin, Amylodextrin, Silica, Dipotassium Glycyrrhizate, Sodium EDTA

PRIMEROSE EGF REPAIRING CREAM

egf cream

PRIMEROSE EGF 
niacinamide, dimethicone, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.015   in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.0004   in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MACADAMIA OIL (UNII: 515610SU8C)  
ARGININE (UNII: 94ZLA3W45F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
POMEGRANATE (UNII: 56687D1Z4D)  
CARAMEL (UNII: T9D99G2B1R)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
AMYLOPECTIN (UNII: 4XO4QFV777)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69888-102-021 in 1 BOX02/13/2018
1NDC:69888-102-01100 mL in 1 CONTAINER; 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(69888-102)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetic Co.,Ltd.689514344manufacture(69888-102)

Revised: 1/2019
Document Id: 7f899eae-76d6-a1e8-e053-2991aa0a0c09
Set id: a0c8db45-e524-4ac0-b83d-e506eb7ba124
Version: 8
Effective Time: 20190115
 
Royal Springs Cosmetics USA, LLC