Otc - Active Ingredient
Benzalkonium Chloride 0.13%
American Hand Sanitizer
FDA Label NDC 79421-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Hand Sanitizer, Llc for the product American Hand Sanitizer (NDC 79421-001). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anitseptic
Indications & Usage
For hand sanitizing to decrease bacteria and viruses on the skin.
Recommended for repeated use.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with eyes.
In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop it 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 the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Read the entire label before using this product.
Pump a small amount of liquid into palm of hand.
Rub thoroughly over all surfaces of both hands for 15 seconds.
Inactive Ingredient
Glycerin, Hydrogen Peroxide, Water
Otc - Questions
Questions?
1-866-443-4509
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