ULTRA WHITENING- niacinamide cream 
MIGUHARA

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.

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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

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)

Revised: 2/2016
Document Id: ab68ef0b-85b0-4c9d-882b-8edbd34efdb9
Set id: e9ce1822-bf52-488d-8c5c-794eb5a13a02
Version: 1
Effective Time: 20160224
 
MIGUHARA