E J Gallo Winery Hand Sanitizer: Package Insert and Label Information

E J GALLO WINERY HAND SANITIZER- alcohol liquid
E. & J. Gallo Winery

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.

Active Ingredient[s] Purpose

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

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

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

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


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

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. If swallowed, get medical help or contact a Poison Control Center immediately.

Glycerin, hydrogen peroxide, purified water USP

Use(s)

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


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.

Front
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Ingredient
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
HYDROGEN PEROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73937-1234-0 750 mL in 1 BOTTLE None
2 NDC:73937-1234-1 187 mL in 1 BOTTLE None
3 NDC:73937-1234-2 20000 mL in 1 CANISTER None
4 NDC:73937-1234-3 48 mL in 1 BOTTLE None
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 Operations
E. & J. Gallo Winery 009200056 manufacture (73937-1234), pack (73937-1234), label (73937-1234)

Revised: 05/2020 E. & J. Gallo Winery

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