Otc - Active Ingredient
Ethyl Alcohol 75% v/v.
Hand Sanitizer
FDA Label NDC 78217-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Frsh Hands Llc for the product Hand Sanitizer (NDC 78217-001). 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 otc - active ingredient, otc - purpose, instructions for use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Instructions For Use
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
- 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.
Otc - Do Not Use
- on 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 right away.
Other Safety Information
Other information
- Store between 15°- 30°C (59°-86°F)
- Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredient
glycerin, hydrogen peroxide, purified water USP
Dosage & Administration
- 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.
Indications & Usage
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Package Label.Principal Display Panel
59.15 mL NDC: 78217-001-01
118.29 mL NDC: 78217-001-02
3785 mL NDC: 78217-001-03
* Please review the disclaimer below.
