DERMA FIRST DUO- glycerin, niacinamide, adenosine 
CELLALAB

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Glycerin, Adenosine

Water, Butylene Glycol, etc.

Skin protectant - Skin Whitening & Wrinkle Improvement

Keep out of reach of the children

- 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.

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.

for external use only

1

DERMA FIRST DUO 
glycerin, niacinamide, adenosine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72312-0004
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0004-11 in 1 CARTON; Type 0: Not a Combination Product03/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 80 mL
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0001 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
NIACINAMIDE (UNII: 25X51I8RD4)  
ADENOSINE (UNII: K72T3FS567)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0002-180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2018
Part 2 of 2
DERMA FIRST AMPOULE 
glycerin, niacinamide, anenosine liquid
Product Information
Item Code (Source)NDC:72312-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0003-150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2018
Labeler - CELLALAB (690452262)
Registrant - CELLALAB (690452262)
Establishment
NameAddressID/FEIBusiness Operations
SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory689851701manufacture(72312-0002, 72312-0003, 72312-0004)
Establishment
NameAddressID/FEIBusiness Operations
CELLALAB690452262relabel(72312-0002, 72312-0003, 72312-0004)

Revised: 5/2018
Document Id: 6d00f08d-3c6a-4ec7-e053-2a91aa0a5e43
Set id: 6cd6c442-d520-a0c9-e053-2991aa0a236f
Version: 2
Effective Time: 20180525
 
CELLALAB