FDA.reportPublic FDA data

ICS3 Antiseptic Foam Hand Wash

Manufacturer
Biocentris Pharmaceuticals, LLC
Effective date
2022-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:03

Label at a glance#

ProductICS3 Antiseptic Foam Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.13% (w/w)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product keep away from eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients

Water, Ethanol, Cocamidopropyl PG-dimonium Chloride Phosphate, Phenoxyethanol, Polyquarternium 11, Decyl Glucoside, Cetrimonium Chloride, Polyquaternium-10, Chlorhexidine Gluconate

SPL UNCLASSIFIED SECTION

Manufactured for

biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-7375

info@biocentris.com • www.biocentris.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iCS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE ANTISEPTIC FOAM HAND WASH

NET CONTENTS 33.8 FL. OZ. (1000 ML)

81232-165 ICS3 FOAM 062281232-165 ICS3 FOAM 0622

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81232-165-102024-01-30C16284748780-11030e365-2a61-111a-e063-dadaa90a10e2ICS3 - Antiseptic Foam Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81232-165-10ICS3 Antiseptic Foam Hand Wash1000 mL in 1 POUCHLIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81232-165ICS3 ANTISEPTIC FOAM HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [BIOCENTRIS PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20220702_e2add183-25c6-d669-e053-2995a90a2911.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81232-16581232-165-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e2add183-25c5-d669-e053-2995a90a2911e2add183-25c6-d669-e053-2995a90a29112022-06-30WarningsExact identifier
spl id: e2add183-25c5-d669-e053-2995a90a2911
spl set id: e2add183-25c6-d669-e053-2995a90a2911

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.