Active Ingredient(S)
Ethyl Alcohol 80% v/v
American Hand Sanitizer
FDA Label NDC 79421-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Hand Sanitizer Llc for the product American Hand Sanitizer (NDC 79421-004). 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 ingredient(s), purpose, use, warnings, 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
Purpose
Antiseptic
Use
For hand sanitizer to decrease bacteria and viruses on the skin.
Recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product avoid contact with eyes. In case of contact with flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours.
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.
Directions
- Read the entire label before using this product.
- Pump a small amout of liquid into palm of hand.
- Rub thoroughly over all surfaces on both hands for 15 seconds
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, water
* Please review the disclaimer below.
