Inopak - ICS3Pink - 162

Inopak - ICS3Pink - 162

Drug Labeling and Warnings

Drug Details

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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 Healthcare Antiseptic product label

ICS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE ANTISEPTIC HAND WASH

Handwash to help reduce bacteria that potentially can cause disease

CHG compatible

Advanced Quat Formulation

biocentris

PHARMACEUTICALS™

50 ml

888-497-4375

[email protected]

www.biocentrispharmaceuticals.com

Inopak ICS3 Pink50

BIO-5077Q-L1000      ICS3®    34 FL OZ  (100 mL)

INFECTION CONTROL SYSTEM 3

ANTISEPTIC HAND WASH

biocentris

PHARMACEUTICALS™

888-497-4375

[email protected]

www.biocentrispharmaceuticals.com

Inopak ICS3 Pink50

Inopak Pink1000

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
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: 10/2019
 
Inopak, Ltd


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