FDA.reportPublic FDA data

ICS3 Blue Healthcare Hand Antiseptic

Manufacturer
Inopak, Ltd
Effective date
2020-02-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:41:48

Label at a glance#

ProductICS3 Blue Healthcare Hand Antiseptic
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

For hand washing 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.

Dosage and administration

If hands are visibly soiled, wash with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 72% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

For hand washing 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

WARNINGS SECTION

  • For external use only. Keep out of eyes, ears or mouth.
  • Discontinue use if irritation occurs.

FLAMMABLE. KEEP AWAY FROM FIRE OF FLAME.

Directions

DOSAGE & ADMINISTRATION SECTION

  • If hands are visibly soiled, wash with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, caprylyl glycol, cetrimonium chloride, chlorhexidine gluconate, Di-PPG-2 myreth-10 adipate, 1,2-hexanediol, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, PPG-3 myristyl ether, water

ICS3 Product Label Blue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO-5076-FL500                                                                                 16.9 FL OZ

Rev. 1.0                               iCS3®                                                     (500 mL)

                                INFECTION CONTROL SYSTEM 3

HEALTHCARE HAND ANTISEPTIC

ETHYL ALCOHOL FOAM

Drug Facts

Active Ingredient                             Purpose

Ethyl Alcohol 72% (v/v) …………… Antiseptic

Uses

For hand washing 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

  • For external use only. Keep out of eyes, ears or mouth.
  • Keep out of reach of children.
  • Discontinue use if irritation occurs

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

Directions

  • If hands are visibly soiled, wash with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Inactive Ingredients

Benzalkonium chloride, caprylyl glycol, cetrimonium chloride, chlorhexidine gluconate, Di-PPG-2 myreth-10 adipate, 1.2-hexanediol, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquatenium 10, PPG-3 myristyl ether, water.

888-497-7375                                                     biocentris

info@biocentris.com                                      PHARMACEUTICALS

www.biocentris.com     

ICS3 LabelICS3 Label

ICS3 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 iCS3®                                                                 HEALTHCARE HAND

INFECTION CONTROL SYSTEM 3               ANTISEPTIC ETHYL

                                                                                                ALCOHOL FOAM

O   6 / 1000 mL Pouches                              O   6/500 mL Pouches                   O  6/1000 mL Cartridges                             

       BIO-5076-FL 1000                                           BIO-5076-FL500                               BIO-5076-OS1000                                       

       040232 65011 6                                           040232 65012 3                             040232 65013 0                                         

O   12 18 oz Bottles                                       O   24 / 50 mL Bottles                   BIO-5076-CASE Rev. 1.0                

       BIO-5076-18                                                      BIO-5076-50                              Call: 888-497-4375                                         

       040232 65015 4                                             040232 65014 7                        www.biocentris.com      

                                                                                                                                                Biocentris

                                                                                                                                                PHARMACEUTICALS

ICS3 CaseICS3 Case

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBP1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E1
DI-PPG-2 MYRETH-10 ADIPATEINACTIVE INGREDIENT4IN301M0KJ1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE OXIDE 600000INACTIVE INGREDIENT2126FD486L1
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)INACTIVE INGREDIENTC7RDC8Y4JS1
PPG-3 MYRISTYL ETHERINACTIVE INGREDIENT7913J43WZ51
WATERINACTIVE INGREDIENT059QF0KO0R1

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
58575-16158575-161-02, 58575-161-10, 58575-161-12, 58575-161-18, 58575-161-80, 58575-161-81, 58575-161-82, 58575-161-83

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
ALCOHOL3K9958V90MACTIB
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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7GEL / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYETHYLENE OXIDE 600000POLYETHYLENE OXIDE 6000002126FD486LTABLET, EXTENDED RELEASE / ORAL189 mgExact identifier — unii candidate
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates

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
946999c0-94c0-403b-a76e-0d55783cf2dbbd7def6d-4b96-45e8-87ac-2c6cf216d0c32020-02-05WarningsExact identifier
spl id: 946999c0-94c0-403b-a76e-0d55783cf2db
spl set id: bd7def6d-4b96-45e8-87ac-2c6cf216d0c3

Reported adverse events (FAERS/openFDA)#

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