XOUL CELL ILLUMINATING 3 STEP MASK- glycerin, adenosine 
PICOSTECH Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

XOUL CELL ILLUMINATING 3 STEP MASK 
glycerin, adenosine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72149-0005
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72149-0005-11 in 1 CARTON; Type 0: Not a Combination Product03/01/201806/26/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 2 mL
Part 21 POUCH 30 mL
Part 31 POUCH 2 mL
Part 1 of 3
XOUL CELL ILLUMINATING AMPOULE 
adenosine gel
Product Information
Item Code (Source)NDC:72149-0006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.01 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72149-0006-12 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201806/26/2018
Part 2 of 3
XOUL CELL ILLUMINATING MASK 
glycerin liquid
Product Information
Item Code (Source)NDC:72149-0007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.21 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72149-0007-130 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34703/01/201806/26/2018
Part 3 of 3
XOUL CELL ILLUMINATING 
glycerin cream
Product Information
Item Code (Source)NDC:72149-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72149-0008-12 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34703/01/201806/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201806/26/2018
Labeler - PICOSTECH Co.,Ltd. (557816754)
Registrant - PICOSTECH Co.,Ltd. (557816754)
Establishment
NameAddressID/FEIBusiness Operations
PICOSTECH Co.,Ltd.557816754manufacture(72149-0005, 72149-0006, 72149-0007, 72149-0008) , label(72149-0005, 72149-0006, 72149-0007, 72149-0008) , pack(72149-0005, 72149-0006, 72149-0007, 72149-0008)
Establishment
NameAddressID/FEIBusiness Operations
JM Medi Bio694857727relabel(72149-0005, 72149-0006, 72149-0007, 72149-0008)

Revised: 6/2018
 
PICOSTECH Co.,Ltd.