FDA.reportPublic FDA data

ICS3 Pink Antiseptic Hand Wash

Manufacturer
Biocentris Pharmaceuticals, LLC
Effective date
2021-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:17

Label at a glance#

ProductICS3 Pink Antiseptic 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

  • Hand wash 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, get medical help or contact a Poison Control Center immediately.

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

Alcohol, Cetrimonium Chloride, Chlorhexidine Gluconate, Cocamidopropyl PG-dimonium Chloride Phosphate, D&C Red #33, Decyl Glucoside, Phenoxyethanol, Polyquaternium 10, Polyquarternium 11, Water.

SPL UNCLASSIFIED SECTION

Developed and Marketed by

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

33.8 fl. oz. (1000 mL)

ICS3 PinkICS3 Pink

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

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
81232-162-032023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash
81232-162-102023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash
81232-162-112023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash
81232-162-182023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash
81232-162-372023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash
81232-162-432023-01-30C16284748780-1f386c64a-28d5-0266-e053-dadaa90a7c1aICS3Pink - Antiseptic Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81232-162-03ICS3 Pink Antiseptic Hand Wash50 mL in 1 BOTTLE, PUMPLIQUID502
81232-162-10ICS3 Pink Antiseptic Hand Wash1000 mL in 1 POUCHLIQUID10002
81232-162-11ICS3 Pink Antiseptic Hand Wash1000 mL in 1 BOTTLE, DISPENSINGLIQUID10002
81232-162-18ICS3 Pink Antiseptic Hand Wash532 mL in 1 BOTTLE, PUMPLIQUID5322
81232-162-37ICS3 Pink Antiseptic Hand Wash3785 mL in 1 BOTTLELIQUID37852
81232-162-43ICS3 Pink Antiseptic Hand Wash1000 mL in 1 CARTRIDGELIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81232-162ICS3 PINK ANTISEPTIC HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [BIOCENTRIS PHARMACEUTICALS, LLC]2Legacy NDC, 6 package rows20210511_b64b1b6e-887d-2300-e053-2a95a90ab65c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81232-16281232-162-03, 81232-162-18, 81232-162-37, 81232-162-11, 81232-162-10, 81232-162-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
D&C RED NO. 339DBA0SBB0LIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ISOPROPYL ALCOHOLND2M416302IACT

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
c1fc3a9b-57d6-6bcb-e053-2995a90a6dacb64b1b6e-887d-2300-e053-2a95a90ab65c2021-05-10WarningsExact identifier
spl id: c1fc3a9b-57d6-6bcb-e053-2995a90a6dac
spl set id: b64b1b6e-887d-2300-e053-2a95a90ab65c

Reported adverse events (FAERS/openFDA)#

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