DERMA FIRST MASK- glycerin kit

Derma First Mask by

Drug Labeling and Warnings

Derma First Mask by is a Otc medication manufactured, distributed, or labeled by CELLALAB, SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin, Adenosine

INACTIVE INGREDIENT

Water, Butylene Glycol, etc.

PURPOSE

Skin Care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children

INDICATIONS & USAGE

Please follow the contents of the label

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

DERMA FIRST MASK 
glycerin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72312-0014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0014-1	1 in 1 KIT; Type 0: Not a Combination Product	06/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	1 mL
Part 2	1 POUCH	25 mL
Part 3	1 POUCH	1 mL

Part 1 of 3

DERMA FIRST AMPOULE 
glycerin gel

Product Information
Item Code (Source)	NDC: 72312-0015
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0015-1	1 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		06/01/2018

Part 2 of 3

DERMA FIRST MASK 
niacinamide liquid

Product Information
Item Code (Source)	NDC: 72312-0016
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0016-1	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		06/01/2018

Part 3 of 3

DERMA FIRST 
glycerin cream

Product Information
Item Code (Source)	NDC: 72312-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	7 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0017-1	1 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
OTC monograph final	part347	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2018

Labeler - CELLALAB (690452262)

Registrant - CELLALAB (690452262)

Establishment
Name	Address	ID/FEI	Business Operations
SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory		689851701	manufacture(72312-0014)

Establishment
Name	Address	ID/FEI	Business Operations
CELLALAB		690452262	label(72312-0014)