ICS3 PINK ANTISEPTIC HAND WASH- benzalkonium chloride liquid

États-Unis - anglais - NLM (National Library of Medicine)

Achète-le

Ingrédients actifs:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Disponible depuis:
Biocentris Pharmaceuticals, LLC
Mode d'administration:
TOPICAL
Type d'ordonnance:
OTC DRUG
indications thérapeutiques:
Purpose Antiseptic Uses - Hand wash to help reduce bacteria on the skin that potentially can cause disease. - Recommended for repeated use.
Statut de autorisation:
OTC monograph not final
Numéro d'autorisation:
81232-162-03, 81232-162-10, 81232-162-11, 81232-162-18, 81232-162-37, 81232-162-43

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ICS3 PINK ANTISEPTIC HAND WASH- benzalkonium chloride liquid

Biocentris Pharmaceuticals, LLC

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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ICS3Pink - Antiseptic Hand Wash

Drug Facts

Active ingredient

Benzalkonium chloride 0.13% (w/w)

Purpose

Antiseptic

Uses

Hand wash to help reduce bacteria on the skin that potentially can cause disease.

Recommended for repeated use.

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.

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

Alcohol, Cetrimonium Chloride, Chlorhexidine Gluconate, Cocamidopropyl PG-dimonium

Chloride Phosphate, D&C Red #33, Decyl Glucoside, Phenoxyethanol, Polyquaternium

10, Polyquarternium 11, Water.

Developed and Marketed by

biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-7375

info@biocentris.com www.biocentris.com

iCS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE ANTISEPTIC FOAM HAND WASH

33.8 fl. oz. (1000 mL)

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)

BENZ ALKONIUM

CHLORIDE

0.13 g

in 100 mL

Biocentris Pharmaceuticals, LLC

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)

Revised: 5/2021

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