Label: NIVEOLA P.H.C 3D FESTIVAL MASK PACK- 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 October 8, 2015

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  • ACTIVE INGREDIENT

    Niacinamide 2.00%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Improves brightness of skin

  • DOSAGE & ADMINISTRATION

    Apply evenly to clean face, avoiding eye area
    Leave on for 10-15 minutes and rinse off thoroughly with warm water

  • 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, Glycerin, Butylene Glycol, Sodium Hyaluronate, Hydrolyzed Collagen, Xanthan Gum, Carbomer, Tocopheryl Acetate, Disodium EDTA, Panthenol, Sea Water, Hippophae Rhamnoides Water, Pearl Extract, Bambusa Vulgaris Extract, Ceramide NP, Cereus Grandiflorus (Cactus) Extract, Caviar Extract, Pisum Sativum (Pea) Extract, Caulerpa Lentillifera Extract, Propolis Extract, Silk Extract, Methylparaben, Portulaca Oleracea Extract, Algae Extract, Aloe Barbadensis Leaf Juice, Beta-Glucan, Allantoin, Triethanolamine, Polysorbate 80, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NIVEOLA P.H.C 3D FESTIVAL MASK PACK 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70133-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.54 g  in 27 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HIPPOPHAE RHAMNOIDES WHOLE (UNII: YAA7TG74X6)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SELENICEREUS GRANDIFLORUS WHOLE (UNII: X8H7HS7MRM)  
    CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
    PEA (UNII: W4X7H8GYFM)  
    CAULERPA LENTILLIFERA (UNII: VJ0188QOU3)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PURSLANE (UNII: M6S840WXG5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CURDLAN (UNII: 6930DL209R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70133-003-0127 g in 1 PACKAGE; Type 0: Not a Combination Product10/08/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/08/2015
    Labeler - Unisource International Co., Ltd. (689517038)
    Registrant - Unisource International Co., Ltd. (689517038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unisource International Co., Ltd.689517038manufacture(70133-003)
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