Label: NOVO PROSERIES FOAMING INSTANT HAND SANITIZER- 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 January 2, 2023

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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 can potentially 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, rinse 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 area under the finger nails and rub until dry.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Cetrimonium Chloride, Lautrimonium Chloride, Phenoxyethanol, Stearalkonium Chloride, Water.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Noble Chemical, Inc.

    2205 Old Philadelphia Pike

    Lancaster, PA 17602

  • PRINCIPAL DISPLAY PANEL

    novo ProSeries

    Foaming Instant Hand Sanitizer

    Benzalkonium chloride 0.1%

    alcohol free

    1000 mL (33.8 FL. OZ.)

    81551-075 Rev

  • INGREDIENTS AND APPEARANCE
    NOVO PROSERIES FOAMING INSTANT HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81551-075
    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:81551-075-011000 mL in 1 POUCH; Type 0: Not a Combination Product04/27/202107/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/202107/05/2024
    Labeler - Noble Chemical (170348663)
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