MOISTIE PURE ESSENCE- niacinamide liquid

MOISTIE PURE ESSENCE by

Drug Labeling and Warnings

MOISTIE PURE ESSENCE by is a Otc medication manufactured, distributed, or labeled by Purecell Korea Co., Ltd., BIO-FD&C. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Niacinamide

INACTIVE INGREDIENT

Water, Glycerin, Butylene Glycol

PURPOSE

Skin Protectant - Whitening

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

Apply daily to your cleansed skin.

Pure Essence can be attached to the Moistie Skin Therapy Steamer and used together with steam to make the skin clear and clean.

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOISTIE PURE ESSENCE 
niacinamide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71609-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0004-1	3 in 1 PACKAGE	06/01/2017
1		10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2017

Labeler - Purecell Korea Co., Ltd. (694667185)

Registrant - Purecell Korea Co., Ltd. (694667185)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C. Co., Ltd.		688203268	manufacture(71609-0004)

Establishment
Name	Address	ID/FEI	Business Operations
Purecell Korea Co., Ltd.		694667185	label(71609-0004)