Label: ICS3 PINK ANTISEPTIC HAND WASH- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 10, 2021

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  • 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)

    ICS3 Pink

  • INGREDIENTS AND APPEARANCE
    ICS3 PINK ANTISEPTIC HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81232-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81232-162-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2014
    2NDC:81232-162-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2014
    3NDC:81232-162-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201405/10/2021
    4NDC:81232-162-111000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/01/201405/10/2021
    5NDC:81232-162-101000 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2014
    6NDC:81232-162-431000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/01/201405/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2014
    Labeler - Biocentris Pharmaceuticals, LLC (015882747)
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