Otc - Active Ingredient
Active ingredient
Benzalkonium Chloride 0.13%
Byotrol Antibacterial Foaming Hand Sanitizer
FDA Label NDC 42719-346
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Byotrol, Inc. for the product Byotrol Antibacterial Foaming Hand Sanitizer (NDC 42719-346). 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
Purpose
Antimicrobial
Indications & Usage
Uses
For hand sanitizing to decrease bacteria 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 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.
Dosage & Administration
DirectionsPump a small amount of foam onto handsRub thoroughly over all surfaces of both handsRub hands together briskly until dry
Inactive Ingredient
Inactive ingredients
Water, Cetrimonium Chloride, Laurtrimonium Chloride, Glycereth-17 Cocoate, Dihydroxyethyl Cocamine Oxide, Polyaminopropyl Biguanide, C8-10-Alkyl Polyglucoside, C12-15 Pareth-7, Citric Acid, Dimethicone
Package Label.Principal Display Panel
100%
Hygeine
Revolution
Byotrol
Alcohol Free
Kills Germs
Antibacterial Foaming
Hand Sanitizer
Powerful
No other FDA compliant hand antiseptic claims more.
Long Lasting
Foaming formula lasts, increasing wet contact time, to deliver the persistent performance Byotrol is known for.
Gentle
Alcohol Free Formula is hard on germs and soft on hands.
byotrol
Net Contents: 42.26 fl.Oz. (1,250ml)
* Please review the disclaimer below.
