Label: PRIMEROSE WHITE MILKY CB- dimethicone, niacinamide, panthenol, adenosine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69888-103-01, 69888-103-02 - 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, Butylene Glycol, Macadamia integrifolia seed oil, Sodium hyaluronate, Glycerin, Cyclohexasiloxane, Cyclopentasiloxane, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Cetyl dimethicone, Cetyl ethylhexanoate, Olea europaea (olive) fruit oil, Titanium Dioxide, Dimethicone/Dimethicone Crosspolymer, Aloe Barbadensis Leaf Extract, Glyceryl Stearate, Cetyl PEG/PPG-10/1 Dimethicone, Hydrolyzed peaprotein, Lecithin, Squalane, Phytosterols, Ceramide 3, Butyspermumpurkii(shea butter), Betaine, Caprylyl Glycol, Allantoin, Beta-Glucan, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Disodium EDTA
- PRIMEROSE WHITE MILKY CB CREAM
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INGREDIENTS AND APPEARANCE
PRIMEROSE WHITE MILKY CB
dimethicone, niacinamide, panthenol, adenosine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69888-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.025 in 80 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.02 in 80 mL PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.005 in 80 mL ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.0004 in 80 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MACADAMIA OIL (UNII: 515610SU8C) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CETYL DIMETHICONE 45 (UNII: IK315POC44) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) OLIVE OIL (UNII: 6UYK2W1W1E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SQUALANE (UNII: GW89575KF9) CERAMIDE 3 (UNII: 4370DF050B) SHEA BUTTER (UNII: K49155WL9Y) BETAINE (UNII: 3SCV180C9W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALLANTOIN (UNII: 344S277G0Z) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69888-103-02 1 in 1 PACKAGE 02/13/2018 1 NDC:69888-103-01 80 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(69888-103) Establishment Name Address ID/FEI Business Operations Royal Springs Cosmetic Co., Ltd. 689514344 manufacture(69888-103)
