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Drug Facts
Manufactured for
biocentris PHARMACEUTICALS
24 Executive Parkway, Ringwood, NJ 07456
888-497-7375
[email protected] • www.biocentris.com
Ics3 Antiseptic Foam Hand Wash
FDA Label NDC 81232-165
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocentris Pharmaceuticals, Llc for the product Ics3 Antiseptic Foam Hand Wash (NDC 81232-165). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Benzalkonium chloride 0.13% (w/w)
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
- Handwash to help reduce bacteria on the skin that potentially can cause disease.
- recommended for repeated use.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product keep away from eyes. In case of eye contact, flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develop or if condition 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.
Dosage & Administration
Directions
- Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds.
- Rinse with water and towel dry.
Inactive Ingredient
Inactive ingredients
Water, Ethanol, Cocamidopropyl PG-dimonium Chloride Phosphate, Phenoxyethanol, Polyquarternium 11, Decyl Glucoside, Cetrimonium Chloride, Polyquaternium-10, Chlorhexidine Gluconate
Package Label.Principal Display Panel
iCS3®
INFECTION CONTROL SYSTEM 3
HEALTHCARE ANTISEPTIC FOAM HAND WASH
NET CONTENTS 33.8 FL. OZ. (1000 ML)
* Please review the disclaimer below.
