Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Hand Protector
FDA Label NDC 79291-653
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cytonix, Llc for the product Hand Protector (NDC 79291-653). 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 - keep out of reach of children, otc - when using, otc - stop use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Antiseptic. Hand and skin sanitizer.
Indications & Usage
USES: to reduce bacteria on skin that could cause disease. Recommended for repeat use.
Warnings
WARNINGS
For external use only.
Do not use in eyes.
When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation and redness develop.
Keep out of reach of children.
If swallowed, get medical attention or contact a Poison Control Center.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - When Using
Avoid contact with eyes. In case of eye contact flush with plenty of water.
Otc - Stop Use
Stop use and ask doctor if irritation or redness develop.
Inactive Ingredient
3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Ethyl Alcohol, Water
Dosage & Administration
Apply liberally to hands and gently rub until dry. Reapply after 4 hours.
Otc - Questions
Contact:
Cytonix LLC, Beltsville, MD
20705 USA 301-470-6267
www.cytonix.com
Package Label.Principal Display Panel
Hand Protector Label
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