H2ONE- ethyl alcohol gel

H2One by

Drug Labeling and Warnings

H2One by is a Otc medication manufactured, distributed, or labeled by Zhejiang Guoyao Jingyue Aerosol Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

FLAMMABLE, KEEP AWAY FROM FIRE

Stop Use and Ask a Doctor

Stop use and ask a doctor if rash or irritation or redness develops and lasts.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place 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.

Other information

Store below 110F(43C)

May discolor certain fabrics or surfaces

Inactive Ingredients

Aqua

Glycerin

Carbomer

Aloe Vera

Triethanolamine

Vitamin E

label

INGREDIENTS AND APPEARANCE

H2ONE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75742-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75742-006-01	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/06/2020
2	NDC: 75742-006-02	375 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/06/2020
3	NDC: 75742-006-03	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/06/2020
4	NDC: 75742-006-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/06/2020
5	NDC: 75742-006-05	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020

Labeler - Zhejiang Guoyao Jingyue Aerosol Co., Ltd. (554529812)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Guoyao Jingyue Aerosol Co., Ltd.		554529812	manufacture(75742-006)