ULTRA WHITENING FIRST ESSENCE- niacinamide cream

Ultra Whitening First Essence by

Drug Labeling and Warnings

Ultra Whitening First Essence by is a Otc medication manufactured, distributed, or labeled by MIGUHARA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ULTRA WHITENING FIRST ESSENCE 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70380-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2.4 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMOMILE (UNII: FGL3685T2X)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70380-330-01	120 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/02/2016

Labeler - MIGUHARA (689204213)

Registrant - MIGUHARA (689204213)

Establishment
Name	Address	ID/FEI	Business Operations
MIGUHARA		689204213	manufacture(70380-330)