FDA.reportPublic FDA data

Journeyman Distillery Hand Sanitizer

Manufacturer
Journeyman Distillery, LLC
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:44

Label at a glance#

ProductJourneyman Distillery Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other information store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40“C (104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 80% v/v

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Use

  • hand sanitizer to help reduce bacteria that potentially can cause disease.
  • for use when soap and water are not available.

WARNINGS SECTION

Warnings
For external use only.

Flammable. Keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use

  • 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.

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 immediately.

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE AND HANDLING SECTION

Other information

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40“C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

JOURNEYMAN DISTILLERY
THREE OAKS, MI 49128
269-820-2050
JOURNEYMANDISTILLERY.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOURNEYMAN Distillery

HAND SANITIZER

WARNING: NOT FOR CONSUMPTION

ALCOHOL ANTISEPTIC 80%

NON-STERILE TOPICAL SOLUTION

2 FL OZ / 59 ML

Journeyman HS 2 oz_FINALJourneyman HS 2 oz_FINAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77395-001-012022-01-28C16284748780-1d6a99b39-3e36-a426-e053-dadaa90af4c2Journeyman Distillery Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77395-001-01Journeyman Distillery Hand Sanitizer59 mL in 1 BOTTLE, SPRAYSOLUTION591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77395-001JOURNEYMAN DISTILLERY HAND SANITIZER (ETHANOL) SOLUTION [JOURNEYMAN DISTILLERY, LLC]1Legacy NDC, 1 package rows20200527_a618bbdd-82e3-2798-e053-2a95a90ad338.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77395-00177395-001-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
a618bbdd-82e2-2798-e053-2a95a90ad338a618bbdd-82e3-2798-e053-2a95a90ad3382020-05-20WarningsExact identifier
spl id: a618bbdd-82e2-2798-e053-2a95a90ad338
spl set id: a618bbdd-82e3-2798-e053-2a95a90ad338

Reported adverse events (FAERS/openFDA)#

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