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JOURNEYMAN DISTILLERY
THREE OAKS, MI 49128
269-820-2050
JOURNEYMANDISTILLERY.COM
Journeyman Distillery Hand Sanitizer
FDA Label NDC 77395-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Journeyman Distillery, Llc for the product Journeyman Distillery Hand Sanitizer (NDC 77395-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Alcohol 80% v/v
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Use
- hand sanitizer to help reduce bacteria that potentially can cause disease.
- for use when soap and water are not available.
Warnings
Warnings
For external use only.
Flammable. Keep away from heat or flame.
Otc - Do Not Use
Do not use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
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
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
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
Other information
- store between 15-30°C (59-86°F)
- avoid freezing and excessive heat above 40“C (104°F)
Inactive Ingredient
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
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
* Please review the disclaimer below.
