Drug Facts

FRESH WATER HAND SANITIZER- 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

Ethyl Alcohol (Alcohol) 62% (w/w)

Glycerin, Carbomer, Green Tea Extract, Aloe Extract, L-Menthol, Aminomethyl Propanol, Water

Antimicrobial

Hand gel for cleaning and moisturizing the hand

KEEP OUT OF REACH OF THE CHILDREN

Store under 30°C (86°F)

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 hands together briskly until dry
Children under 6 years of age should be supervised when using this product

FRESH WATER HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74773-0012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
LEVOMENTHOL (UNII: BZ1R15MTK7)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74773-0012-1	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/2020

Labeler - THESKINFACTORY Co., Ltd. (694804099)

Registrant - THESKINFACTORY Co., Ltd. (694804099)

Name	Address	ID/FEI	Business Operations
Establishment
Soleo Cosmetic Co., Ltd.		557829412	manufacture(74773-0012)

Name	Address	ID/FEI	Business Operations
Establishment
THESKINFACTORY Co., Ltd.		694804099	label(74773-0012)