FDA.reportPublic FDA data

ICS3 Blue Healthcare Hand Antiseptic

Manufacturer
Biocentris Pharmaceuticals, LLC
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:49

Label at a glance#

ProductICS3 Blue Healthcare Hand Antiseptic
Active ingredientALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Alcohol 72% (v/v)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • To decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment.
  • Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.​ Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product keep out of 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

  • Wet all surfaces of both hands thoroughly with product, including under the fingernails.
  • Rub hands together and allow to dry without wiping.

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzalkonium Chloride, Caprylyl Gycol, Cetrimonium Chloride, Chlorhexidine Gluconate, Di-PPG-2 Myreth-10 Adipate, 1,2-Hexanediol, Isopropyl Alcohol, PEG-10 Dimethicone, Polyethylene Oxide 600000, Phenoxyethanol, Polyquaternium 10, PPG-3 Myristyl Ether, Water

SPL UNCLASSIFIED SECTION

Developed and Marketed by biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-4375

info@biocentris.com • www.biocentris.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE HAND ANTISEPTIC

ALCOHOL FOAM

16.9 FL OZ (500 mL)

ICS3 Blue_500mL Apr 2021ICS3 Blue_500mL Apr 2021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1085908ethanol 72 % Topical FoamPSN2
1085908ethanol 0.72 ML/ML Topical FoamSCD2
1085908ethanol 72 % Topical FoamSY2

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81232-161-02ICS3 Blue Healthcare Hand Antiseptic60 mL in 1 BOTTLELIQUID602
81232-161-03ICS3 Blue Healthcare Hand Antiseptic50 mL in 1 BOTTLELIQUID502
81232-161-10ICS3 Blue Healthcare Hand Antiseptic1000 mL in 1 POUCHLIQUID10002
81232-161-12ICS3 Blue Healthcare Hand Antiseptic1250 mL in 1 POUCHLIQUID12502
81232-161-17ICS3 Blue Healthcare Hand Antiseptic500 mL in 1 POUCHLIQUID5002
81232-161-18ICS3 Blue Healthcare Hand Antiseptic540 mL in 1 BOTTLE, PUMPLIQUID5402
81232-161-43ICS3 Blue Healthcare Hand Antiseptic1000 mL in 1 CARTRIDGELIQUID10002
81232-161-80ICS3 Blue Healthcare Hand Antiseptic800 mL in 1 POUCHLIQUID8002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81232-161ICS3 BLUE HEALTHCARE HAND ANTISEPTIC (ETHYL ALCOHOL) LIQUID [BIOCENTRIS PHARMACEUTICALS, LLC]2Legacy NDC, 8 package rows20210421_b64abdb6-2f55-22e4-e053-2a95a90a05e0.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81232-16181232-161-02, 81232-161-10, 81232-161-12, 81232-161-18, 81232-161-80, 81232-161-17, 81232-161-43, 81232-161-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
DI-PPG-2 MYRETH-10 ADIPATE4IN301M0KJIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYETHYLENE OXIDE 6000002126FD486LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)C7RDC8Y4JSIACT
PPG-3 MYRISTYL ETHER7913J43WZ5IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
c06a68af-a5e7-99f6-e053-2a95a90aaf43b64abdb6-2f55-22e4-e053-2a95a90a05e02021-04-20WarningsExact identifier
spl id: c06a68af-a5e7-99f6-e053-2a95a90aaf43
spl set id: b64abdb6-2f55-22e4-e053-2a95a90a05e0

Reported adverse events (FAERS/openFDA)#

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