Four Fathers Distillery

Manufacturer
Four Fathers Distillery LLC
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:12

Label at a glance#

ProductFour Fathers Distillery Alcohol Antiseptic 80%
Active ingredientALCOHOL
Label structure9 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 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

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

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

When using this product keep out of 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 serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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 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

SPL UNCLASSIFIED SECTION

Alcohol Antiseptic 80%/ Topical Solution

Hand Sanitizer/ Non-Sterile Solution

904-710-6150

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distil1Distil1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78829-100-382022-01-28C16284748780-1d6a99b39-6330-a426-e053-dadaa90af4c2Four Fathers Distillery Alcohol Antiseptic 80%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78829-100-38Four Fathers DistilleryAlcohol Antiseptic 80%3785 mL in 1 JUGSOLUTION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78829-100FOUR FATHERS DISTILLERY ALCOHOL ANTISEPTIC 80% (ALCOHOL) SOLUTION [FOUR FATHERS DISTILLERY LLC]2Legacy NDC, 1 package rows20201009_1c05b115-840d-448a-8d70-78e4f03698dd.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78829-10078829-100-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
bfb7fa27-733e-4d3f-9cdc-8bd5d5ba2a0f1c05b115-840d-448a-8d70-78e4f03698dd2020-10-08WarningsExact identifier
spl id: bfb7fa27-733e-4d3f-9cdc-8bd5d5ba2a0f
spl set id: 1c05b115-840d-448a-8d70-78e4f03698dd

Reported adverse events (FAERS/openFDA)#

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