QUEEN PURECELL WHITENING 3-STEP MASK- niacinamide, adenosine kit

QUEEN PURECELL WHITENING 3-STEP MASK by

Drug Labeling and Warnings

QUEEN PURECELL WHITENING 3-STEP MASK by is a Otc medication manufactured, distributed, or labeled by Purecell Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

NIACINAMIDE, ADENOSINE

INACTIVE INGREDIENT

Water, Butylene Glycol, Glycerin, Sodium Hyaluronate, Allantoin, etc.

PURPOSE

WHITENING & ANTI-WRINKLE

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

1. Cleanse skin with toner to clear up skin texture.
2. Massage the highly enriched ampoule in STEP 1 to face for sufficient absorption.
3. Spread the mask sheet in STEP 2 onto entire face.
4. Remove the mask after 15-20 minutes and massage the repair finalizing cream in STEP 3 onto face for absorption.

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

QUEEN PURECELL WHITENING 3-STEP MASK 
niacinamide, adenosine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71609-0005

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0005-2	4 in 1 PACKAGE	06/01/2017
1	NDC: 71609-0005-1	1 in 1 POUCH; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	1.5 mL
Part 2	1 POUCH	30 g
Part 3	1 POUCH	1.5 g

Part 1 of 3

QUEEN PURECELL WHITENING FAST REPAIRING AMPOULE 
niacinamide, adenosine liquid

Product Information
Item Code (Source)	NDC: 71609-0008
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
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0008-1	1.5 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		06/01/2017

Part 2 of 3

QUEEN PURECELL WHITENING AND REPAIR MASK SHEET 
niacinamide, adenosine patch

Product Information
Item Code (Source)	NDC: 71609-0006
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 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0006-1	30 g 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		06/01/2017

Part 3 of 3

QUEEN PURECELL WHITENING REPAIR FINALIZING 
niacinamide, adenosine cream

Product Information
Item Code (Source)	NDC: 71609-0007
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 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71609-0007-1	1.5 g 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		06/01/2017

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
Purecell Korea Co., Ltd.		694667185	label(71609-0005) , pack(71609-0005) , manufacture(71609-0005)