Label: ICS3 BLUE HEALTHCARE HAND ANTISEPTIC- alcohol 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 April 26, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 70% (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

    • Apply liberally to hands to cover all surfaces.
    • Rub hands together until dry.
    • Supervise children under 6 years old.
    • Not recommended for infants.
  • INACTIVE INGREDIENT

    Inactive ingredients Benzalkonium Chloride, Chlorhexidine Gluconate, Isopropyl Alcohol, PEG-10 Dimethicone, Polyethylene Oxide 600000, Phenoxyethanol, Polyquaternium 10, Water

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    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)

    ICS3 Blue 81232-150

  • INGREDIENTS AND APPEARANCE
    ICS3 BLUE HEALTHCARE HAND ANTISEPTIC 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81232-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81232-150-101000 mL in 1 POUCH; Type 0: Not a Combination Product04/26/2022
    2NDC:81232-150-17500 mL in 1 POUCH; Type 0: Not a Combination Product04/26/2022
    3NDC:81232-150-431000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product04/26/2022
    4NDC:81232-150-18532 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/26/2022
    Labeler - Biocentris Pharmaceuticals, LLC (015882747)
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