Label: ULTRA WHITENING FIRST ESSENCE- 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: Chamomilla Recutita (Matricaria) Flower Water, Glycerin, Dipropylene Glycol, Beta-Glucan, Sodium Hyaluronate, Urtica Dioica (Nettle) Extract, Ecklonia Cava Extract, Camellia Sinensis Leaf Extract, Allium Cepa (Onion) Bulb Extract, 1,2-Hexanediol, Lactobacillus/Punica Granatum Fruit Ferment Extract, accharomyces/Linseed Oil Ferment, Glycosyl Trehalose, PEG-60 Hydrogenated Castor Oil, Piper Methysticum Leaf/Root/Stem Extract, Camellia Sinensis Catechins, Xanthan Gum, Disodium EDTA, Citrus Paradisi (Grapefruit) Peel Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. For external use only 4. Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Usage

    Usage: Apply smoothly on the entire face in the morning and night.

  • Usage

    Usage: Apply smoothly on the entire face in the morning and night.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTRA WHITENING FIRST ESSENCE 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.4 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHAMOMILE (UNII: FGL3685T2X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-330-01120 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(70380-330)