XOUL Y ZONE BEAUTY SERUM- glycerin gel
PICOSTECH Co.,Ltd.

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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Drug Facts

GLYCERIN

Water, Butylene Glycol, 1,2-Hexanediol, Human Adipocyte Conditioned Media Extract, Ceramide NP, Allantoin, Octapeptide-7, Copper Tripeptide-1, sh-Pentapeptide-19, etc.

Skin protectant

keep out of reach of the children

Apply proper amount to the skin.

•Precautions when using

1. After using or using cosmetics, consult a specialist if you have any abnormal symptoms such as red spots, swelling or itching or side effects caused by direct sunlight.

2. Do not use on wounded area

3. storage and handling Precautions

a) Keep out of the reach of children

b) Store away from direct sunlight.

for external use only

XOUL Y ZONE BEAUTY SERUM
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72149-0002
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72149-0002-1	10 in 1 BOX	03/01/2018	06/26/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	03/01/2018	06/26/2018

Labeler - PICOSTECH Co.,Ltd. (557816754)

Registrant - PICOSTECH Co.,Ltd. (557816754)

Name	Address	ID/FEI	Business Operations
Establishment
PICOSTECH Co.,Ltd.		557816754	manufacture(72149-0002) , pack(72149-0002) , label(72149-0002)

Name	Address	ID/FEI	Business Operations
Establishment
JM MEDIBIO		694857727	relabel(72149-0002)

Revised: 6/2018

Document Id: 6f961381-c112-5298-e053-2a91aa0adf19

Set id: 67d1b121-ec68-0794-e053-2991aa0a6e80

Version: 2

Effective Time: 20180626

PICOSTECH Co.,Ltd.