HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Casey Jones Distillery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient(s)

Alcohol 80% v/v

Purpose

Antiseptic

USES

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:

• on children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

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

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

DIRECTIONS

• Place enough product on hands to cover all surfaces.
• Rub hands together until dry.
• Supervise children under 6 years when using this product to avoid swallowing.

OTHER INFORMATION

Store between 15°- 30°C (59°- 86°F)

Avoid freezing and excessive heat above 40°C (104°F)

INACTIVE INGREDIENTS

Glycerin, Hydrogen Peroxide, Purifi‹ed Water USP

PRINCIPAL DISPLAY PANEL - 1892.71 ML Container Label

Hand
SANITIZER

ALCOHOL ANTISEPTIC 80% TOPICAL
NON-STERILE SOLUTION

CASEY JONES
DISTILLERY

MADE and BOTTLED in HOPKINSVILLE, KENTUCKY
2 QUART ( 1892.71 ML)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77121-247
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)
Hydrogen Peroxide (UNII: BBX060AN9V)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77121-247-02	1892.71 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
2	NDC: 77121-247-01	3785.42 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
3	NDC: 77121-247-03	946.353 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
4	NDC: 77121-247-04	354.882 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
5	NDC: 77121-247-05	236.588 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
6	NDC: 77121-247-06	118.294 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	03/23/2020

Labeler - Casey Jones Distillery (054068273)

Establishment
Name	Address	ID/FEI	Business Operations
Casey Jones Distillery		054068273	MANUFACTURE(77121-247)