FDA.reportPublic FDA data

ICS3 Pink Healthcare Antiseptic Hand

Manufacturer
Inopak, Ltd
Effective date
2020-02-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:41:45

Label at a glance#

ProductICS3 Pink Healthcare Antiseptic Hand
Active ingredientBENZALKONIUM CHLORIDE
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

Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds Rinse with water and towel dry.

Label contents#

Full prescribing information#

Drug FactsActive Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% (w/w)

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
  • Rinse with water and towel dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetrimonium cloride, chlorhexidine glluconate, cocamidopropyl PG-dimonium chloride phosphate, D & C Red #33, decyl glucoside, ethyl alcohol, phenoxyethanol, polyquaternium 10, polyquarternium 11, water.

ICS3 Pink label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIO-5077Q-FL 1000                                                                          34 FL OZ

Rev. 1.02                             iCS3®                                                     (1000 mL)

                                INFECTION CONTROL SYSTEM 3                  Bio-5077Q-FL

ANTISEPTIC HAND WASH

Drug Facts

Active Ingredient                             Purpose

Benzalkonium chloride ..………… 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.
  • Discontinue use if irritation occurs
  • Keep out of reach of children.

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 Ingredients

Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, D&C Red # 33, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquaternium 11, water

888-497-7375                                                     biocentris

info@biocentris.com                                      PHARMACEUTICALS

www.biocentris.com

ICS3 pinkICS3 pink

ICS3 Pink Case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iCS3®                                                                  ANTISEPTIC FOAM

INFECTION CONTROL SYSTEM 3                             HAND WASH

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

       BIO-5077Q-FL1000                                         BIO-5077Q-OS1000                                                   

       040232 65000 0                                           040232 65001 7                                                                      

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

       BIO-5077Q-18                                                  BIO-5077Q-50                           Call: 888-497-4375                                         

       040232 65002 4                                             040232 65003 1                        info@biocentris.com

                                                                                                                                                www.biocentris.com      

                                                                                                                                                Biocentris

                                                                                                                                                PHARMACEUTICALS

ICS3 Pink CaseICS3 Pink Case

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBP1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E1
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM41
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6Y1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)INACTIVE INGREDIENTC7RDC8Y4JS1
POLYQUATERNIUM-11 (1000000 MW)INACTIVE INGREDIENT0B44BS5IJS1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-16258575-162-02, 58575-162-18, 58575-162-01, 58575-162-10, 58575-162-11, 58575-162-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
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

Source Document#

Source XML · Source PDF

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 2 · 79 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET / ORAL0.24 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / DENTALNAExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSYRUP / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LELIXIR / ORAL27.5 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 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
a09e26a0-f932-4b21-88bf-ce6628faad45291e37dd-010b-4c56-adc3-9ad8bbd394682020-02-05WarningsExact identifier
spl id: a09e26a0-f932-4b21-88bf-ce6628faad45
spl set id: 291e37dd-010b-4c56-adc3-9ad8bbd39468

Reported adverse events (FAERS/openFDA)#

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