DERMA FIRST DUO- glycerin, niacinamide, adenosine kit

Derma First Duo by

Drug Labeling and Warnings

Derma First Duo 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 protectant - Skin Whitening & Wrinkle Improvement

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children

INDICATIONS & USAGE

- Derma First Mist: Spray the mist evenly on entire face after cleansing. Pat gently until it is fully absorbed. In case of sensitive skin, spray on hands and apply to face.

- Derma First Ampoule: Apply 2 or 3 drops on the face after using Derma First Mist. Gently pat on eye, mouth and nose area for better absorption.

WARNINGS

1. Discontinue use and ask a doctor if any adverse reactions occur such as rash, swelling or irritation after use or due to direct sunlight.
2. Do not use on damaged or broken skin.
3. Storage and Handling Precautions

(A)Keep out of reach of children.

(B)Keep out of direct sunlight.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMA FIRST DUO 
glycerin, niacinamide, adenosine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72312-0004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0004-1	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, SPRAY	80 mL
Part 2	1 BOTTLE, DROPPER	50 mL

Part 1 of 2

DERMA FIRST MIST 
glycerin, niacinamide, adenosine liquid

Product Information
Item Code (Source)	NDC: 72312-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.0001 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72312-0002-1	80 mL in 1 BOTTLE, SPRAY; 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	03/01/2018

Part 2 of 2

DERMA FIRST AMPOULE 
glycerin, niacinamide, anenosine liquid

Product Information
Item Code (Source)	NDC: 72312-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.15 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: 72312-0003-1	50 mL in 1 BOTTLE, DROPPER; 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	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2018

Labeler - CELLALAB (690452262)

Registrant - CELLALAB (690452262)

Establishment
Name	Address	ID/FEI	Business Operations
SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory		689851701	manufacture(72312-0002, 72312-0003, 72312-0004)

Establishment
Name	Address	ID/FEI	Business Operations
CELLALAB		690452262	relabel(72312-0002, 72312-0003, 72312-0004)