Label: TOAS REJUVENATION- 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 September 24, 2018

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  • ACTIVE INGREDIENT

    Niacinamide 0.5%

  • PURPOSE

    Brightening

  • INDICATIONS & USAGE

    Helps brightness and moisturizing

  • DOSAGE & ADMINISTRATION

    Apply an appropriate amount and Pat on skin with fingertips, AM and PM.

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Olea Europaea (Olive) Fruit Oil, 1.2-Hexanediol, Glycerin, Betaine, Cetearyl Alcohol, Macadamia Integrifolia Seed Oil, Vitis Vinifera (Grape) Seed Oil, Beeswax, PEG/PPG-17/6 Copolymer, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Glyceryl Stearate, Sorbitan Sesquioleate, Glycereth-26, Stearic Acid, Arginine, PEG-100 Stearate, Carbomer, Sodium Hyaluronate, Fragrance, Xanthan Gum, Centella Asiatica Extract, Tocopheryl Acetate, Ethylhexylglycerin, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Lecithin, Adenosine, Hydrogenated Lecithin, Oligopeptide-1

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TOAS REJUVENATION 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72557-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.15 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BETAINE (UNII: 3SCV180C9W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72557-004-021 in 1 CARTON09/24/2018
    1NDC:72557-004-0130 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/24/2018
    Labeler - TOAS Co., Ltd. (694485346)
    Registrant - TOAS Co., Ltd. (694485346)
    Establishment
    NameAddressID/FEIBusiness Operations
    TOAS Co., Ltd.694485346manufacture(72557-004)