Label: BENZALKONIUM CHLORIDE swab

  • NDC Code(s): 10819-3740-1
  • Packager: Professional Disposables International, Inc.
  • 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 October 20, 2021

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

  • USE

    For hand washing to decrease bacteria on the skin.

  • PURPOSE

    Antiseptic handwash

  • WARNINGS

    • For external use only.
    • If swallowed, get medical help or contact a Poison Control Center right away.
    • Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
    • Do not use in the eyes.
  • Keep out of reach of children.

    Keep out of reach of children.

  • DIRECTIONS

    • Tear open packet.
    • Unfold and use; discard in trash receptacle after single use.
    • Wet hands thoroughly with product and allow to dry without wiping.
  • OTHER INFORMATION

    Lot number and expiration date can be found on back panel of packet.

  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Disodium EDTA, Potassium Sorbate, PPG-2 Hydroxyethyl Cocamide, Purified Water

  • SPL UNCLASSIFIED SECTION

    Professional Disposables International, Inc.
    Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
    Made in USA

  • ACTIVE INGREDIENT

    Benzalkonium Chloride, 0.13% w/w

  • DOSAGE

    Wet hands thoroughly with product and allow to dry without wiping.

  • PRINCIPAL DISPLAY PANEL-100 COUNT

    Packet

    packet

    Box

    box

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3740-13 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2012
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-3740)