ICS3 PINK HEALTHCARE ANTISEPTIC HAND- benzalkonium chloride liquid 
Inopak, Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Inopak - ICS3Pink - 162

Drug Facts
Active Ingredient

Benzalkonium chloride 0.13% (w/w)

Purpose

Antiseptic

Keep out of reach of children.

  • Keep out of reach of children.

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.

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 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

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 pink

ICS3 Pink Case

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 Case

ICS3 PINK HEALTHCARE ANTISEPTIC HAND 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58575-162-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2014
2NDC:58575-162-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2014
3NDC:58575-162-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2014
4NDC:58575-162-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/01/2014
5NDC:58575-162-111000 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2014
6NDC:58575-162-121000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/2014
Labeler - Inopak, Ltd (194718243)
Registrant - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-162)

Revised: 2/2020
Document Id: a09e26a0-f932-4b21-88bf-ce6628faad45
Set id: 291e37dd-010b-4c56-adc3-9ad8bbd39468
Version: 7
Effective Time: 20200205
 
Inopak, Ltd