ICS3 Blue Healthcare Hand Antiseptic

ICS3 Blue Healthcare Hand Antiseptic

Drug Labeling and Warnings

Drug Details

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ICS3 BLUE HEALTHCARE HAND ANTISEPTIC- ethyl alcohol 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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ICS3 Blue Healthcare Hand Antiseptic

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

ICS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE HAND ANTISEPTIC

ETHYL ALCOHOL FOAM

Handwash to help reduce bacteria that potentially can cause disease

For Use Without Water

biocentris

Pharmaceuticals

50 mL

888-497-4375

[email protected]

www.biocentrispharmaceuticals.com

ICS3 Label

ICS3 BLUE HEALTHCARE HAND ANTISEPTIC 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL56.525 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-161-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2014
2NDC: 58575-161-101000 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2014
3NDC: 58575-161-121250 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2014
4NDC: 58575-161-18540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2014
5NDC: 58575-161-80800 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2014
Labeler - Inopak, Ltd (194718243)
Registrant - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-161)

Revised: 10/2019
 
Inopak, Ltd


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