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 Biocentris Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Alcohol 72% (v/v)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• 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

Warnings

For external use only.​ Flammable. Keep away from fire or flame.

When using this product keep out of eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• Wet all surfaces of both hands thoroughly with product, including under the fingernails.
• Rub hands together and allow to dry without wiping.

INACTIVE INGREDIENT

Inactive ingredients Benzalkonium Chloride, Caprylyl Gycol, Cetrimonium Chloride, Chlorhexidine Gluconate, Di-PPG-2 Myreth-10 Adipate, 1,2-Hexanediol, Isopropyl Alcohol, PEG-10 Dimethicone, Polyethylene Oxide 600000, Phenoxyethanol, Polyquaternium 10, PPG-3 Myristyl Ether, Water

SPL UNCLASSIFIED SECTION

Developed and Marketed by biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-4375

info@biocentris.com www.biocentris.com

PRINCIPAL DISPLAY PANEL

ICS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE HAND ANTISEPTIC

ALCOHOL FOAM

16.9 FL OZ (500 mL)

INGREDIENTS AND APPEARANCE

ICS3 BLUE HEALTHCARE HAND ANTISEPTIC 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81232-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  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: 81232-161-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2014	04/20/2021
2	NDC: 81232-161-10	1000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
3	NDC: 81232-161-12	1250 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014	04/20/2021
4	NDC: 81232-161-18	540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2014	04/20/2021
5	NDC: 81232-161-80	800 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014	04/20/2021
6	NDC: 81232-161-17	500 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2014
7	NDC: 81232-161-43	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/01/2014
8	NDC: 81232-161-03	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 - Biocentris Pharmaceuticals, LLC (015882747)