Label: DR. COLOR EFFECT RED- niacinamide cream

  • 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

    Active Ingredient: Niacinamide 2.0%

  • 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

    Purpose: Skin Protectant

  • 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

    Keep out of reach of children: Keep out of reach of babies and children

  • INDICATIONS & USAGE

    Indications & Usage: Apply smoothly on the entire face in the morning and night.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product after toner and essence. To feel stronger effect, please use it with RED SERUM

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    DR. COLOR EFFECT RED 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69679-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69679-020-0150 mL in 1 CARTON; Type 0: Not a Combination Product02/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/23/2016
    Labeler - ES PURE VINE INC. (079733519)
    Registrant - LAB & Company Inc. (688284779)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAB & Company Inc.688284779manufacture(69679-020)