FRESH WATER HAND SANITIZER- alcohol gel

Fresh Water Hand Sanitizer by

Drug Labeling and Warnings

Fresh Water Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Soleo Cosmetic Co., Ltd., THE SKINFACTORY Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

PURPOSE

Antimicrobial

Hand gel for cleaning and moisturizing the hand

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Store under 30°C (86°F)

WARNINGS

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.

DOSAGE & ADMINISTRATION

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESH WATER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71693-600
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71693-600-01	2 in 1 PACKAGE	03/01/2020
1		100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2020

Labeler - Soleo Cosmetic Co., Ltd. (557829412)

Registrant - THE SKINFACTORY Co., Ltd. (694804099)

Establishment
Name	Address	ID/FEI	Business Operations
Soleo Cosmetic Co., Ltd.		557829412	manufacture(71693-600)

Establishment
Name	Address	ID/FEI	Business Operations
THE SKINFACTORY Co., Ltd.		694804099	label(71693-600)