E J GALLO WINERY HAND SANITIZER liquid

E J Gallo Winery Hand Sanitizer by

Drug Labeling and Warnings

E J Gallo Winery Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by E. & J. Gallo Winery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient[s] Purpose

Alcohol 80% v/v ........................................................................................................ Anitseptic

PURPOSE

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

DO NOT USE

Do not use
in children less than 2 months of age
on open skin wounds

STOP USE

Stop use and ask a doctor if irritation or rash occurs. this may be a sign of a serious condition.

WHEN USING

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Glycerin, hydrogen peroxide, purified water USP

INDICATIONS & USAGE

Use(s)

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available.

DOSAGE & ADMINISTRATION

Directions
place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise Children under 6 years of age to prevent swallowing.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

E J GALLO WINERY HAND SANITIZER 
e j gallo winery hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73937-1234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73937-1234-0	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2020
2	NDC: 73937-1234-1	187 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2020
3	NDC: 73937-1234-2	20000 mL in 1 CANISTER; Type 0: Not a Combination Product	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/16/2020

Labeler - E. & J. Gallo Winery (009200056)

Registrant - E. & J. Gallo Winery (009200056)

Establishment
Name	Address	ID/FEI	Business Operations
E. & J. Gallo Winery		009200056	manufacture(73937-1234) , pack(73937-1234) , label(73937-1234)