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Ultra Whitening

Medically reviewed on February 26, 2018.

Dosage form: cream
Ingredients: Niacinamide 1.0g in 50mL
Labeler: MIGUHARA
NDC Code: 70380-340

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.

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

ULTRA WHITENING 
niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-340
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (NIACINAMIDE) Niacinamide1.0 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:70380-340-0150 mL in 1 CARTON
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/FEIOperations
MIGUHARA689204213manufacture(70380-340)

 
MIGUHARA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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