Label: AQUACIL- 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 June 7, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium chloride 0.1% (w/w)

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Pump sufficient amount of foam into palm of hand.
    • Wet all surfaces of both hands thoroughly with product, including the area under the fingernails.
    • Rub hands together until dry.
  • INACTIVE INGREDIENT

    Inactive ingredients Cetrimonium Chloride, Laurtrimonium Chloride, Phenoxyethanol, Stearalkonium Chloride, Water.

  • SPL UNCLASSIFIED SECTION

    Developed and Marketed by biocentris PHARMACEUTICALS

    24 Executive Parkway, Ringwood, NJ 07456

    888-497-4373

    info@biocentris.com • www.biocentris.com

  • PRINCIPAL DISPLAY PANEL

    AQUACIL®
    FOAMING HAND SANITIZER

    Benzalkonium Chloride 0.1%

    KILLS 99.9% OF GERMS
    Alcohol Free Formula

    33.8 fl oz (1000 mL)

    Aquacil Instant Foaming HS_BZK

  • INGREDIENTS AND APPEARANCE
    AQUACIL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81232-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81232-170-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2013
    2NDC:81232-170-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/201306/07/2021
    3NDC:81232-170-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201306/07/2021
    4NDC:81232-170-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/201306/07/2021
    5NDC:81232-170-431000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product05/01/2013
    6NDC:81232-170-101000 mL in 1 POUCH; Type 0: Not a Combination Product05/01/2013
    7NDC:81232-170-17532 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2013
    Labeler - Biocentris Pharmaceuticals, LLC (015882747)
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