ICS3 BLUE HEALTHCARE HAND ANTISEPTIC- ethyl alcohol liquid

ICS3 Blue Healthcare Hand Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 72% (v/v)

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.

FLAMMABLE. KEEP AWAY FROM FIRE OF 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, polyquaternium 10, PPG-3 myristyl ether, water

ICS3 Product Label Blue

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 case

 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

INGREDIENTS AND APPEARANCE

ICS3 BLUE HEALTHCARE HAND ANTISEPTIC 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	56.525 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-161-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014
2	NDC: 58575-161-10	1000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
3	NDC: 58575-161-12	1250 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
4	NDC: 58575-161-18	540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2014
5	NDC: 58575-161-80	800 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
6	NDC: 58575-161-81	500 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
7	NDC: 58575-161-82	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/01/2014
8	NDC: 58575-161-83	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2014

Labeler - Inopak, Ltd (194718243)

Registrant - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-161)