Label: DR. COLOR EFFECT RED- niacinamide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69679-020-01 - Packager: ES PURE VINE INC.
- 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 February 23, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Dipropylene Glycol, Glycerin, Butylene Glycol, Ethylhexyl Stearate, Cyclopentasiloxane, Biosaccharide Gum-1, Sodium Polyacrylate, Hydrolyzed Glycosaminoglycans, Punica Granatum Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Chamaemorus Fruit Extract, Lycium Chinense Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Lepidium Sativum Sprout Extract, Carthamus Tinctorius (Safflower) Flower Extract, Rosa Rugosa Flower Extract, Paeonia Albiflora Flower Extract, Tulipa Darwin Flower Extract, Camellia Japonica Flower Extract, Rosa Hybrid Flower Extract, Polyglutamic Acid, Beta-Glucan, Sodium Hyaluronate, Lithospermum Erythrorhizon Root Oil, Bis-Stearyl Peg/PPG-8/6 SMDI/Peg-400 Copolymer, Allantoin, Betaine, Panthenol, Rosa Damascena Callus Culture Extract, Sodium Polyacryloyldimethyl Taurate, Hydrogenated Polydecene, Trideceth-10, Caprylhydroxamic Acid, Caprylyl Glycol, Boswellia Serrata Resin Extract, Dipotassium Glycyrrhizate, Adenosine, Rose Flower Oil, Ethylhexylglycerin, 1,2-Hexanediol, Fragrance
- PURPOSE
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WARNINGS
Warnings: 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. For external use only
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. COLOR EFFECT RED
niacinamide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69679-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 1 g in 50 mL Inactive Ingredients Ingredient Name Strength FRAGARIN (UNII: 0416TL8388) VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1) RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6) LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q) RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K) LEPIDIUM SATIVUM WHOLE (UNII: 0FL88F2R2Q) ABELMOSCHUS MANIHOT FLOWER (UNII: 7HR1YQC68U) PAEONIA SUFFRUTICOSA FLOWER OIL (UNII: P3X14HXC1L) TULIPA KAUFMANNIANA BULB (UNII: 831WJ3WD14) ADENOSINE (UNII: K72T3FS567) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) ROSA RUGOSA FLOWER (UNII: 969IQC5YJU) 1,4-DIPHENYL-1,3-BUTADIENE (UNII: CTQ3U893LX) ALLANTOIN (UNII: 344S277G0Z) DIHYDROXYETHYL STEARAMINE OXIDE (UNII: G67739LV1T) PANTHENOL (UNII: WV9CM0O67Z) ROSA DAMASCENA FLOWERING TOP (UNII: 21W82Q764G) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIDECETH-10 (UNII: G624N6MSBA) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYLENE GLYCOL (UNII: FC72KVT52F) GLYCERIN (UNII: PDC6A3C0OX) 1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) POMEGRANATE (UNII: 56687D1Z4D) EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) CAMELLIA JAPONICA FLOWER OIL (UNII: 5CXP06X16D) GLATIRAMER ACETATE (UNII: 5M691HL4BO) ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ROSA CANINA WHOLE (UNII: P5R39F12N2) POLYGALIC ACID (UNII: XCC6WEA55L) CURDLAN (UNII: 6930DL209R) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) LITHOSPERMUM ERYTHRORHIZON ROOT (UNII: 9I70D8O47I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69679-020-01 50 mL in 1 CARTON; Type 0: Not a Combination Product 02/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/23/2016 Labeler - ES PURE VINE INC. (079733519) Registrant - LAB & Company Inc. (688284779) Establishment Name Address ID/FEI Business Operations LAB & Company Inc. 688284779 manufacture(69679-020)