Label: COSTEM CELL 5 N- niacinamide solution

  • Category: HUMAN OTC DRUG LABEL

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 November 17, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Human Stem Cell Conditioned Media, Glycerin, Butylene Glycol, Panthenol, Polysorbate 20, Copper Tripeptide-1, Acetyl Hexapeptide-8, Tripeptide-29, Palmitoyl Pentapeptide-4 , Nicotinoyl Tripeptide-1, Nicotinoyl Dipeptide-22, Nicotinoyl Dipeptide-23, Nonapeptide-1, sh-oligopeptide-1, sh-polypeptide-1, sh-polypeptide-11, sh-polypeptide-10, sh-polypeptide-9, sh-oligopeptide-2, Caprylyl Glycol, 1,2-Hexanediol, Polysorbate 60, Betaine, Squalane, Cucumis Sativus (Cucumber) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Argania Spinosa Kernel Oil, Pinus Densiflora Leaf Extract, Chamaecyparis Obtusa Oil, Sodium Hyaluronate, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Pentylene glycol, Panax Ginseng Root Extract, Astragalus Membranaceus Root Extract, Morus Alba Bark Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Extract, Sodium Phosphate, Lecithin, Superoxide Dismutase, Caprylhydroxamic Acid, Allantoin, Adenosine, Disodium EDTA

  • PURPOSE

    Purpose: Skin Brightening

  • WARNINGS

    Warnings: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Rinse with water to remove. Stop use if a rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: Apply it to your face focusing on the oily parts, using the spray gently and evenly

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product. Use Once or several times a day.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    COSTEM CELL 5 N 
    niacinamide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71044-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.1 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71044-010-0218 in 1 CARTON11/01/2016
    1NDC:71044-010-015 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2016
    Labeler - COSTEMCELL.LTD.CO (689851859)
    Registrant - COSTEMCELL.LTD.CO (689851859)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSTEMCELL.LTD.CO689851859manufacture(71044-010)