Buffalo Trace Hand Sanitizer by Sazerac Company, Inc.

Buffalo Trace Hand Sanitizer by

Drug Labeling and Warnings

Buffalo Trace Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sazerac Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BUFFALO TRACE HAND SANITIZER- alcohol solution 
Sazerac Company, Inc.

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.

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Drug Facts

Active Ingredient([s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]  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  in 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 of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

BUFFALO TRACE​®

DISTILLERY

HAND

SANITIZER

Alcohol Antiseptic 80%

Topical Solution

C02.001766

100ML

NON-STERILE SOLUTION

NON-POTABLE

Bottled by Sazerac Company, Inc. Louisville, KY, 866-729-3722
0  88004 04130  4

C02.001766

100 mL

200 mL

Case Label

res

BUFFALO TRACE HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75089-201
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: 75089-201-01	48 in 1 CASE	06/10/2020
1		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 75089-201-02	48 in 1 CASE	06/10/2020
2		200 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	06/10/2020	12/01/2022

Labeler - Sazerac Company, Inc. (078761784)

Registrant - Sazerac Company, Inc. (078761784)

Revised: 12/2022

Document Id: c59ed1e5-debe-46f8-b83b-f5c6b8d86e23

34390-5

Set id: f8f193fc-7192-4bcb-a5e8-da731bb9c415

Version: 2

Effective Time: 20221228