Label: GINSENG WHITENING- niacinamide cream

  • 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 September 19, 2016

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  • Active Ingredients

    Niacinamide (2%)

  • Purpose

    Skin Protectant/ brightening care

  • Uses

    Helps to reduce the appearance of wrinkle, moisturize and brighten skin.

  • Keep out of reach of children

    Do not swallow. In case of accidental ingestion, seek professional assistance.

  • 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

    Apply the adequate amount on skin anytime with a light pressing motion every day. Use more than twice a day.

  • Inactive Ingredients

    D.I. Water, 1,3 Butylene Glycol, Cethylethyl Hexanoate, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Oleate, Cetearyl Alcohol, Lecithin, Glyceryl Stearate, Tranexamic Acid, 1,2 Hexandiol, Ginsenoside, Glycerylstearate, PEG-100 Stearate, Polyglyceryl -3, Methylglucos Distearate, Citrus Paradisi (Grapefruit) Fruit Extract, Sodium Hyaluronate, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Arnica Montana Flower Extract, Portulaca Oleracea Extract, Camellia Sinensis Leaf Extract, Poloxamer 407, Polysorbate 80, Isohexadecane, Phenoxyethanol, Citric Acid, Perfume

  • Ginseng Whitening Cream

    ginseng whitening cream

  • INGREDIENTS AND APPEARANCE
    GINSENG WHITENING 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70969-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    Glycerin (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Glyceryl Oleate (UNII: 4PC054V79P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GINSENOSIDES (UNII: 3K198YD54P)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PURSLANE (UNII: M6S840WXG5)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70969-101-021 in 1 PACKAGE09/19/2016
    1NDC:70969-101-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/19/2016
    Labeler - Synbio Co., Ltd. (557821393)
    Registrant - Synbio Co., Ltd. (557821393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Synbio Co., Ltd.557821393manufacture(70969-101)