Label: ULTRA WHITENING- 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 24, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Camellia Sinensis Leaf Extract, Glycerin, Ethylhexyl PalmitateEthylhexyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer /Cyclomethicone/Hydrogenated Lecithin/Alcohol/Aqua, Helianthus Annuus (Sunflower) Seed Oil, Allium Cepa (Onion) Bulb Extract, Beta-Glucan, Ceramide/Phospholipids/Phytosterols/Soybean Glycerides/ Stearyl Alcohol /Behenyl Alcohol, Cetearyl Alcohol, Cyclomethicone, 1,2-Hexanediol, Panthenol, Urtica Dioica (Nettle) Extract, Argania Spinosa Kernel Oil, Sodium Hyaluronate, Beeswax, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Dimethicone, Ecklonia Cava Extract, Tocopheryl Acetate, Arginine, Carbomer, Palmitoyl Dipeptide-7, Xanthan Gum, Allantoin, Disodium EDTA, Citrus Paradisi (Grapefruit) Peel Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. According to supporting evidence that prove its effect. It causes slight papular and uredo, when applying the same contained ingredient medicine.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Usage

    Usage: Take an appropriate amount and gently apply it on the face

  • Usage

    Usage: Take an appropriate amount and gently apply it on the face

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTRA WHITENING 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide1.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-340-0150 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIGUHARA689204213manufacture(70380-340)