DERMA FIRST MASK- glycerin 
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 Care

Keep out of reach of the children

Please follow the contents of the label

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

for external use only

label

DERMA FIRST MASK 
glycerin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72312-0014
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0014-11 in 1 KIT; Type 0: Not a Combination Product06/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 1 mL
Part 21 POUCH 25 mL
Part 31 POUCH 1 mL
Part 1 of 3
DERMA FIRST AMPOULE 
glycerin gel
Product Information
Item Code (Source)NDC:72312-0015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0015-11 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2018
Part 2 of 3
DERMA FIRST MASK 
niacinamide liquid
Product Information
Item Code (Source)NDC:72312-0016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0016-125 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2018
Part 3 of 3
DERMA FIRST 
glycerin cream
Product Information
Item Code (Source)NDC:72312-0017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72312-0017-11 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2018
Labeler - CELLALAB (690452262)
Registrant - CELLALAB (690452262)
Establishment
NameAddressID/FEIBusiness Operations
SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory689851701manufacture(72312-0014)
Establishment
NameAddressID/FEIBusiness Operations
CELLALAB690452262label(72312-0014)

Revised: 6/2018
Document Id: 6f708a11-83f3-a9c1-e053-2a91aa0a28d4
Set id: 6f708a11-83f2-a9c1-e053-2a91aa0a28d4
Version: 1
Effective Time: 20180624
 
CELLALAB