Otc - Active Ingredient
Alcohol 80%
Hand Sanitizer
FDA Label NDC 74008-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Watershed Distillery Llc for the product Hand Sanitizer (NDC 74008-0001). 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 otc - active ingredient, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - stop use, otc - 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
Otc - Do Not Use
Do not use:
In children less than 2 months of age
On open skin wounds
Otc - 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.
Otc - Purpose
Use(s)
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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
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 & 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.
Warnings
For external use only. Flammable. Keep away from heat or flame.
For external use only. Flammable. Keep away from heat or flame.
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
Usage: 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.
Package Label.Principal Display Panel
Hand Sanitizer
Non-Sterile Solution
Denatured Alcohol Antiseptic 80%
Topical Solution
______mL ________ BATCH
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