ICS3 PINK HEALTHCARE ANTISEPTIC HAND- benzalkonium chloride liquid

ICS3 Pink Healthcare Antiseptic Hand by

Drug Labeling and Warnings

ICS3 Pink Healthcare Antiseptic Hand by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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 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

INGREDIENTS AND APPEARANCE

ICS3 PINK HEALTHCARE ANTISEPTIC HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-162-02	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2014
2	NDC: 58575-162-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2014
3	NDC: 58575-162-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2014
4	NDC: 58575-162-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/01/2014
5	NDC: 58575-162-11	1000 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2014
6	NDC: 58575-162-12	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2014

Labeler - Inopak, Ltd (194718243)

Registrant - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-162)