Active Ingredients & Back Label
Active ingredient(s)
Alcohol 80% v/v.......Antiseptic
Black Diamond Distillery Hand Sanitizer
FDA Label NDC 74815-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hocking Technical College for the product Black Diamond Distillery Hand Sanitizer (NDC 74815-0001). 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 active ingredients & back label, do not use, keep out of reach of children, purpose, stop use, when using, other safety information, warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Do Not Use
Do not use
- in children less than 2 months of age
- on open skin wounds
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Use(s)
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Other Safety Information
Other information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Warnings And Precautions
Warnings
For external use only Flammable. Keep away from heat or flame.
Instructions For Use
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.
Inactive Ingredient
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
Dosage And 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.
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame
Do no use
- in children less than 2 months of age
- on open skin wounds
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.
Indications & Usage Section
Use(s)
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.
Package Label Principal Display Panel
New Straitsville
(Black Diamond Distillery logo image)
Black Diamond
Distillery
Hand Sanitizer
Alcohol Antiseptic 80%
Topical Solution
WHO Recommended Antiseptic Hand Rub
Formulation #1
FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
NON-STERILE SOLUTION
NET WT: 1 GAL. (3785.41mL)
Black Diamond Distillery
105 W. Main Street, P.O. Box 495
New Straitsville, Ohio 43766
Made in USA
(Hocking College Logo image)
DATE:_______BATCH:_______
EXPIRES 30 DAYS FROM DATE ABOVE
* Please review the disclaimer below.
