FDA.reportPublic FDA data

28 Mile Tough Town Hand Sanitizer

Manufacturer
28 Mile Vodka Company LLC
Effective date
2020-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:40

Label at a glance#

Product28 Mile Tough Town Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin

Dosage and administration

* Place enough product on hands to cover all surfaces * Rub Hands together until dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Hand and Skin Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin

Warning

WARNINGS SECTION

For extgernal 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

* Irritation or rash occurs

Stop use and ask docotr if

OTC - STOP USE SECTION

* redness or skin irritation develop after use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Supervise children under 6 years of age when using this product to avoid swallowing

Directions

DOSAGE & ADMINISTRATION SECTION

* Place enough product on hands to cover all surfaces

* Rub Hands together until dry

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerine, PEG-6, Acrylates/Vinyl Cross polymer, Polyethylene Glycol, 1,2,3 - Propanetriol, 1,3-Propanediamine, Gycerol, Xanthan Gum, Maltodextrin, Fragrance

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28 Mile Tough Town Hand sanitizer

Tough Town Hand Sanitizer

Cumuber Mint Scented

Lavebder Rose Scented

Unscented

For external use only,

Do not Drink

28 Mile Distilling Company and Tough Town Hand Sanitizer are aptly named after Highwood, IL, the place we call home. Situated just 28 miles north of Chicago, Highwood had a reputation that once led President Theodore Roosevelt to call it "the toughest town in America". Out toughness and resiliency still holds true today as is reflected in the products we produce. Stay safe, stay clean, stay tough.

Produce by:

28 Mile Distilling Co.

454 Sheridon Road, Highwood

IL 60040

Alcohol Antiseptic 70% Topical Solution

Hand Sanitizer Non-sterile solution

NDC: 77340-004-xx; 77340-005-xx; 77340-006-xx; 77340-007-xx; 77340-008-xx; 77340-009-xx

009-04-Hand sanitizer009-04-Hand sanitizer

008-04-Hand sanitizer008-04-Hand sanitizer

007-05-Hand sanitizer007-05-Hand sanitizer

007-04-Hand sanitizer007-04-Hand sanitizer

006-05-Hand sanitizer006-05-Hand sanitizer

006-04-Hand sanitizer006-04-Hand sanitizer

005-04-Hand sanitizer005-04-Hand sanitizer

004-04-Hand sanitizer004-04-Hand sanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77340-004-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-005-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-006-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-006-052023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-007-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-007-052023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-008-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts
77340-009-042023-01-30C16284748780-1f386c64a-220c-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77340-004-0428 Mile Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
77340-005-0428 Mile Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
77340-006-0428 Mile Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
77340-006-0528 Mile Tough Town Hand Sanitizer3785.41 mL in 1 BOTTLE, PUMPGEL3785.411
77340-007-04Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
77340-007-05Tough Town Hand Sanitizer3785 mL in 1 BOTTLE, PUMPGEL37851
77340-008-04Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731
77340-009-04Tough Town Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77340-00428 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 1 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip
77340-00528 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 1 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip
77340-00628 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 2 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip
77340-00728 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 2 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip
77340-00828 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 1 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip
77340-00928 MILE TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL TOUGH TOWN HAND SANITIZER (ETHYL ALCOHOL) GEL [28 MILE VODKA COMPANY LLC]1Legacy NDC, 1 package rows20201031_aebf09e4-5a7f-c968-e053-2a95a90ab18b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77340-00477340-004-04
77340-00577340-005-04
77340-00677340-006-05, 77340-006-04
77340-00777340-007-04, 77340-007-05
77340-00877340-008-04
77340-00977340-009-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
RAPIDGEL EZ133JH4A7R2KIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
RAPIDGEL EZ133JH4A7R2KIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
WATER059QF0KO0RIACT
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
ALCOHOL3K9958V90MACTIB
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MALTODEXTRIN7CVR7L4A2DIACT
ALCOHOL3K9958V90MACTIB
XANTHAN GUMTTV12P4NEEIACT
MALTODEXTRIN7CVR7L4A2DIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
RAPIDGEL EZ133JH4A7R2KIACT

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
aebf09e4-5a80-c968-e053-2a95a90ab18baebf09e4-5a7f-c968-e053-2a95a90ab18b2020-10-30WarningsExact identifier
spl id: aebf09e4-5a80-c968-e053-2a95a90ab18b
spl set id: aebf09e4-5a7f-c968-e053-2a95a90ab18b

Reported adverse events (FAERS/openFDA)#

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