Drug Facts

DRYOPE FRESH PURE HAND- alcohol gel
THESKINFACTORY 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

Alcohol

Glycerin, Carbomer, etc.

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

For the external use only

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Put enough product in your palm to thoroughly cover your hands.

Rub your hands together briskly until dry.

Chidren under 6 years of age should be supervised when using this product.

DRYOPE FRESH PURE HAND
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74773-0002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74773-0002-1	62 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2020

Labeler - THESKINFACTORY Co., Ltd. (694804099)

Registrant - THESKINFACTORY Co., Ltd. (694804099)

Name	Address	ID/FEI	Business Operations
Establishment
Ester Co., Ltd.		688425766	manufacture(74773-0002)

Name	Address	ID/FEI	Business Operations
Establishment
THESKINFACTORY Co., Ltd.		694804099	label(74773-0002)