Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Anti-microbial Alcohol Free Hand Sanitizer
FDA Label NDC 79208-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultra Chem Labs for the product Anti-microbial Alcohol Free Hand Sanitizer (NDC 79208-001). 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 - keep out of reach of children, otc - stop use, otc - when using, other safety information, inactive ingredient, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 - Stop Use
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
Otc - When Using
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water
Other Safety Information
Directions • Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands for 15 seconds • Rinse with potable water
Inactive Ingredient
Inactive ingredients Water, laurtrimonium chloride, alkyl polyglucoside, uv indicator cocamidopropylamine oxide, alkyl polyglycoside, citric acid
Warnings
Warnings
For external use only
Dosage & Administration
Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands for 15 seconds • Rinse with potable water
Indications & Usage
• For hand washing to decrease bacteria on the skin
• Recommended for repeated use
Otc - Purpose
Antimicrobial
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