Label: PRIMEROSE EGF- niacinamide, dimethicone, adenosine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69888-102-01, 69888-102-02 - Packager: Royal Springs Cosmetics USA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 15, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Keep out of reach of children
- Uses
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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
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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
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INGREDIENTS AND APPEARANCE
PRIMEROSE EGF
niacinamide, dimethicone, adenosine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69888-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.02 in 100 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.015 in 100 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.0004 in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69888-102-02 1 in 1 BOX 02/13/2018 1 NDC:69888-102-01 100 mL in 1 CONTAINER; 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(69888-102) Establishment Name Address ID/FEI Business Operations Royal Springs Cosmetic Co.,Ltd. 689514344 manufacture(69888-102)
