DR. GLODERM TABRX WHITENING MASK- niacinamide kit

DR. GLODERM TABRX WHITENING MASK by

Drug Labeling and Warnings

DR. GLODERM TABRX WHITENING MASK by is a Otc medication manufactured, distributed, or labeled by DR.GLODERM, EYESEL Co., Ltd., KOREA DERMAL RESEARCH CENTER CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Step1(Mask): Niacinamide
• Step2(Oil Capsule): Glycerin

INACTIVE INGREDIENT

• Step1: Water, Glycerin, Butylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, etc
• Step2: Hydrogenated Polydecene, Hydrogenated Vegetable Oil, etc

PURPOSE

Skin Protectant - Whitening

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Step1

1. Refine skin with using a toner after cleansing face.
2. Apply mask on the face and take a rest 10~20 minutes.
3. Remove mask and gently pat remaining essence until fully absorbed.

Step2

1. After using mask, open the capsule pouch and take it out.
2. Gently twist the tip of capsule and squeeze onto your fingertips.
3. Pour the oil into the palm and smoothe over face.

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. GLODERM TABRX WHITENING MASK 
niacinamide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71342-0007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71342-0007-1	10 in 1 PACKAGE	03/23/2017
1		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	25 mL
Part 2	1 POUCH	0.3 mL

Part 1 of 2

DR. GLODERM TABRX WHITENING MASK 
niacinamide liquid

Product Information
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		25 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other

Part 2 of 2

DR. GLODERM TABRX OILCAPSULE 
glycerin oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.3 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/23/2017

Labeler - DR.GLODERM (694773267)

Registrant - DR.GLODERM (694773267)

Establishment
Name	Address	ID/FEI	Business Operations
EYESEL Co., Ltd.		557836898	manufacture(71342-0007)

Establishment
Name	Address	ID/FEI	Business Operations
KOREA DERMAL RESEARCH CENTER CO., LTD.		694640098	manufacture(71342-0007)

Establishment
Name	Address	ID/FEI	Business Operations
DR.GLODERM		694773267	label(71342-0007)