Drug Facts

DIONA CELL REGENERATION BOOSTER- glycerin liquid
VAATZ 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, 1,2-HEXANEDIOL, ADENOSINE, BUTYLENE GLYCOL, ETC.

Skin protectant

keep out of reach of the children

Apply an appropriate amount to skin and absorb it.

1) If following symptoms occur after product use, stop using immediately and consult with a specialist: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

for external use only

DIONA CELL REGENERATION BOOSTER
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72573-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.045 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72573-0001-1	12 in 1 BOX	09/01/2018
1		5 mL in 1 VIAL; 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	09/01/2018

Labeler - VAATZ CO., LTD. (695058942)

Registrant - VAATZ CO., LTD. (695058942)

Name	Address	ID/FEI	Business Operations
Establishment
EYESEL Co., Ltd.		557836898	manufacture(72573-0001)

Name	Address	ID/FEI	Business Operations
Establishment
VAATZ CO., LTD.		695058942	label(72573-0001)