SAZERAC COMPANY HAND SANITIZER- alcohol solution

Sazerac Company Hand Sanitizer by

Drug Labeling and Warnings

Sazerac Company Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sazerac Company, Inc., Barton 1792 Distillery, Sazerac of Indiana LLC, The Glenmore Distillery, Buffalo Trace Distillery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient[s]  Alcohol 80%

PURPOSE

Purpose Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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

OTHER SAFETY INFORMATION

Other information
Inactive ingredients glycerin, hydrogen peroxide, purified water
Store between 15-30c (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water

Product Package Labeling

Alcohol Antiseptic 80% Topical Solution

Hand Sanitizer

Non-Sterile Solution Non-Potable

SINCE 1850

SAZERAC

NEW ORLEANS

Bottled by Sazerac Company, Inc.
Louisville, KY  866-729-3722

1.75L

750mL

375mL

200mL

100 mL

Case Label

res

INGREDIENTS AND APPEARANCE

SAZERAC COMPANY HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75089-001
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: 75089-001-01	6 in 1 CASE	04/08/2020
1		1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 75089-001-02	12 in 1 CASE	04/08/2020
2		750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 75089-001-03	24 in 1 CASE	04/08/2020
3		375 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 75089-001-04	48 in 1 CASE	04/08/2020
4		200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 75089-001-05	48 in 1 CASE	04/08/2020
5		100 mL in 1 BOTTLE, PLASTIC; 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	part333A	04/08/2020

Labeler - Sazerac Company, Inc. (078761784)

Registrant - Sazerac Company, Inc. (078761784)

Establishment
Name	Address	ID/FEI	Business Operations
Barton 1792 Distillery		006375695	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Barton Brands of California		079136259	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Sazerac Distillers LLC		066152942	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Sazerac of Indiana LLC		108912685	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
The Glenmore Distillery		058517786	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Buffalo Trace Distillery		082735320	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Boston Brands of Maine		079430721	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Bowman Distillery Incorporated, A. Smith		003239340	manufacture(75089-001)

Establishment
Name	Address	ID/FEI	Business Operations
Sazerac of New Hampshire LLC		070417900	manufacture(75089-001)