Label: VIROCLEAR- 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

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzalkonium Chloride 0.12% w/w.

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    • Hand sanitizer to decrease bacteria on the skin.
    • For use when soap and water are not available.
  • Warnings

    For external use only.

    When using this product

    When using this product, keep out of eyes, ears and mouth. In case ofcontact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    Discontinue use if irritation and redness develops.

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

  • Directions

    Apply 2-3 sprays onto dry hands and rub hands together vigorously.

  • Other information

    Store in a cool dry place below 104º F.

  • Inactive Ingredients

    Water/Aqua, Leptospermum Petersonii (Lemon Bush) Leaf Extract, Matricaria Chamomilla (Chamomile) Flower Extract.

  • Questions or comments

    Call +1 905 542 2900

  • Package Label - Principal Display Panel

    50 mL; NDC 81909-0001-1

    ViroClear 50ml Label

  • INGREDIENTS AND APPEARANCE
    VIROCLEAR 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81909-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81909-0001-150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/07/2021
    Labeler - Bioinnovate Pty Ltd (747092416)