Active Ingredient
Benzalkonium Chloride 0.13% w/w
E2 Sanitizing Hand Soap
FDA Label NDC 50865-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kutol Products Company for the product E2 Sanitizing Hand (NDC 50865-017). 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, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antibacterial Agent
Uses
For handwashing to help reduce bacteria on the skin that could cause disease.
Warnings
For external use only. Avoid contact with eyes. If contact occurs, flush with water.
Otc - Stop Use
Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Directions
To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.
Inactive Ingredients
Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.
Otc - Questions
Kutol Product Co.
Cincinnati, OH 45241
www.Kutol.com
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