FDA.reportPublic FDA data

ETHYL ALCOHOL

Manufacturer
Bushmill's Ethanol Inc.
Effective date
2020-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:05:19

Label at a glance#

ProductETHYL ALCOHOL
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

109777000 mL NDC: 74630-8303-4109777000 mL NDC: 74630-8303-41249000 mL NDC: 74630-0002-21249000 mL NDC: 74630-0002-230238000 mL NDC: 74630-0002-330238000 mL NDC: 74630-0002-330238000 mL NDC: 74630-0001-330238000 mL NDC: 74630-0001-330238000 mL NDC: 74630-8303-330238000 mL NDC: 74630-8303-31249000 ml NDC: 74630-8303-21249000 ml NDC: 74630-8303-2189000 mL NDC: 74630-0002-1189000 mL NDC: 74630-0002-1109777000 mL NDC: 74630-0002-4109777000 mL NDC: 74630-0002-4109777000 mL NDC: 74630-0001-4109777000 mL NDC: 74630-0001-4189000 mL NDC: 74630-8303-1189000 mL NDC: 74630-8303-1189000 mL NDC: 74630-0001-1189000 mL NDC: 74630-0001-11249000 mL NDC: 74630-0001-21249000 mL NDC: 74630-0001-2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74630-0001-12021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0001-22021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0001-32021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0001-42021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0002-12021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0002-22021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0002-32021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-0002-42021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-8303-12021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-8303-22021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-8303-32021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7
74630-8303-42021-07-23C16284748780-1c7ccaba7-13da-fd44-e053-dadaa90aa01ba253aa27-a352-83c4-e053-2a95a90af3c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74630-0001-1Denatured DT Ethyl Alcohol189000 mL in 1 DRUMLIQUID1890002
74630-0001-2Denatured DT Ethyl Alcohol1249000 mL in 1 TANKLIQUID12490002
74630-0001-3Denatured DT Ethyl Alcohol30238000 mL in 1 TANKLIQUID302380002
74630-0001-4Denatured DT Ethyl Alcohol109777000 mL in 1 TANKLIQUID1097770002
74630-0002-1Denatured D Ethyl Alcohol189000 mL in 1 DRUMLIQUID1890002
74630-0002-2Denatured D Ethyl Alcohol1249000 mL in 1 TANKLIQUID12490002
74630-0002-3Denatured D Ethyl Alcohol30238000 mL in 1 TANKLIQUID302380002
74630-0002-4Denatured D Ethyl Alcohol109777000 mL in 1 TANKLIQUID1097770002
74630-8303-1ETHYL ALCOHOL189000 mL in 1 DRUMLIQUID1890002
74630-8303-2ETHYL ALCOHOL1249000 mL in 1 TANKLIQUID12490002
74630-8303-3ETHYL ALCOHOL30283000 mL in 1 TANKLIQUID302830002
74630-8303-4ETHYL ALCOHOL109777000 mL in 1 TANKLIQUID1097770002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74630-0001ETHYL ALCOHOL (ALCOHOL) LIQUID DENATURED DT ETHYL ALCOHOL (DENATURED ALCOHOL) LIQUID DENATURED D ETHYL ALCOHOL (DENATURED ETHYL ALCOHOL) LIQUID [BUSHMILL'S ETHANOL INC.]2Legacy NDC, 4 package rows20200408_a253aa27-a352-83c4-e053-2a95a90af3c7.zip
74630-0002ETHYL ALCOHOL (ALCOHOL) LIQUID DENATURED DT ETHYL ALCOHOL (DENATURED ALCOHOL) LIQUID DENATURED D ETHYL ALCOHOL (DENATURED ETHYL ALCOHOL) LIQUID [BUSHMILL'S ETHANOL INC.]2Legacy NDC, 4 package rows20200408_a253aa27-a352-83c4-e053-2a95a90af3c7.zip
74630-8303ETHYL ALCOHOL (ALCOHOL) LIQUID DENATURED DT ETHYL ALCOHOL (DENATURED ALCOHOL) LIQUID DENATURED D ETHYL ALCOHOL (DENATURED ETHYL ALCOHOL) LIQUID [BUSHMILL'S ETHANOL INC.]2Legacy NDC, 4 package rows20200408_a253aa27-a352-83c4-e053-2a95a90af3c7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74630-830374630-8303-1, 74630-8303-2, 74630-8303-3, 74630-8303-4
74630-000174630-0001-1, 74630-0001-2, 74630-0001-3, 74630-0001-4
74630-000274630-0002-1, 74630-0002-2, 74630-0002-3, 74630-0002-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2b4f3c0-3ffa-48bb-e053-2a95a90a3b90a253aa27-a352-83c4-e053-2a95a90af3c72020-04-07WarningsExact identifier
spl id: a2b4f3c0-3ffa-48bb-e053-2a95a90a3b90
spl set id: a253aa27-a352-83c4-e053-2a95a90af3c7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.