Label: PDI BENZALKONIUM CHLORIDE ANTISEPTIC TOWELETTES- bzk cloth

  • 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 May 7, 2012

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  • Use

    For hand washing to decrease bacteria on the skin
  • Warnings

    • Flammable, keep away from fire or flame.
    • 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.
  • Directions


    • Tear open packet.
    • Unfold and use; discard after single use.
    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other information

    Lot No. and Expiration Date can be found on back panel of packet.

    Dosage


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

    USP Purified Water

  • SPL UNCLASSIFIED SECTION

    Professional Disposables International, Inc.
    Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
    www.pdipdi.com              Made in USA
  • Principal Display Panel - 100 Count

    PDI
    Benzalkonium Chloride
    Antiseptic Towelettes

    For Professional and Hospital Use

    1 Towelette [7.7 x 5.0 in (19.6 x 12.7 cm)] 100 Towelettes per Box

    Packet Label
    Image of Packet Label
    Box Label
    Image of Box Label
  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antiseptic handwash

  • INGREDIENTS AND APPEARANCE
    PDI BENZALKONIUM CHLORIDE  ANTISEPTIC TOWELETTES
    bzk cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3737
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3737-1100 in 1 BOX
    13.0 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/1983
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture
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