MOISTIE PURE ESSENCE: Package Insert and Label Information

MOISTIE PURE ESSENCE- niacinamide liquid
Purecell Korea Co., Ltd.

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.

Niacinamide

Water, Glycerin, Butylene Glycol

Skin Protectant — Whitening

keep out or reach of the children

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.

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

for external use only

MOISTIE PURE ESSENCE niacinamide liquid

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN BUTYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71609-0004-1 3 VIAL in 1 PACKAGE contains a VIAL 1 10 mL in 1 VIAL This package is contained within the PACKAGE (71609-0004-1)

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	Operations
BIO-FD&C. Co., Ltd.		688203268	manufacture (71609-0004)

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

Revised: 08/2017 Purecell Korea Co., Ltd.