ETHYL ALCOHOL- alcohol liquid 
DENATURED DT ETHYL ALCOHOL- denatured alcohol liquid 
DENATURED D ETHYL ALCOHOL- denatured ethyl alcohol liquid 
Bushmill's Ethanol 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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

109777000 mL NDC: 74630-8303-41249000 mL NDC: 74630-0002-230238000 mL NDC: 74630-0002-330238000 mL NDC: 74630-0001-330238000 mL NDC: 74630-8303-31249000 ml NDC: 74630-8303-2189000 mL NDC: 74630-0002-1109777000 mL NDC: 74630-0002-4109777000 mL NDC: 74630-0001-4189000 mL NDC: 74630-8303-1189000 mL NDC: 74630-0001-11249000 mL NDC: 74630-0001-2

ETHYL ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74630-8303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74630-8303-1189000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:74630-8303-21249000 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
3NDC:74630-8303-330283000 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
4NDC:74630-8303-4109777000 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
DENATURED DT ETHYL ALCOHOL 
denatured alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74630-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74630-0001-1189000 mL in 1 DRUM; Type 0: Not a Combination Product04/07/2020
2NDC:74630-0001-21249000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
3NDC:74630-0001-330238000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
4NDC:74630-0001-4109777000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
DENATURED D ETHYL ALCOHOL 
denatured ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74630-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74630-0002-1189000 mL in 1 DRUM; Type 0: Not a Combination Product04/07/2020
2NDC:74630-0002-21249000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
3NDC:74630-0002-330238000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
4NDC:74630-0002-4109777000 mL in 1 TANK; Type 0: Not a Combination Product04/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Bushmill's Ethanol Inc. (152955394)
Establishment
NameAddressID/FEIBusiness Operations
Bushmill's Ethanol Inc.152955394manufacture(74630-8303, 74630-0001, 74630-0002)

Revised: 4/2020
Document Id: a2b4f3c0-3ffa-48bb-e053-2a95a90a3b90
Set id: a253aa27-a352-83c4-e053-2a95a90af3c7
Version: 2
Effective Time: 20200407
 
Bushmill's Ethanol Inc.