ICS3 PINK ANTISEPTIC HAND WASH- benzalkonium chloride liquid

ICS3 Pink Antiseptic Hand Wash by

Drug Labeling and Warnings

ICS3 Pink Antiseptic Hand Wash 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

Benzalkonium chloride 0.13% (w/w)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• Hand wash to help reduce bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

WARNINGS

Warnings

For external use only.

When using this product keep away from 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

• Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds.
• Rinse with water and towel dry.

INACTIVE INGREDIENT

Inactive ingredients

Alcohol, Cetrimonium Chloride, Chlorhexidine Gluconate, Cocamidopropyl PG-dimonium Chloride Phosphate, D&C Red #33, Decyl Glucoside, Phenoxyethanol, Polyquaternium 10, Polyquarternium 11, Water.

SPL UNCLASSIFIED SECTION

Developed and Marketed by

biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-7375

info@biocentris.com www.biocentris.com

PRINCIPAL DISPLAY PANEL

iCS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE ANTISEPTIC FOAM HAND WASH

33.8 fl. oz. (1000 mL)

INGREDIENTS AND APPEARANCE

ICS3 PINK ANTISEPTIC HAND WASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81232-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81232-162-03	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2014
2	NDC: 81232-162-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2014
3	NDC: 81232-162-37	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2014	05/10/2021
4	NDC: 81232-162-11	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/01/2014	05/10/2021
5	NDC: 81232-162-10	1000 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2014
6	NDC: 81232-162-43	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/01/2014	05/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2014

Labeler - Biocentris Pharmaceuticals, LLC (015882747)