Label: HARBOR MIST E2 SANITIZING FOAM WITH BZK- benzalkonium chloride liquid

  • NDC Code(s): 81792-004-01
  • Packager: Von Drehle Corporation
  • Category: HUMAN OTC DRUG LABEL

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 1, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses:

    For hand washing to decrease bacteria on the skin.

    Recommended for repeated use.

  • Warnings:

    For external use only.

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, 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.

  • Directions:

    Directions:

    Pump a small amount of foam into palm of hand.

    Rub thoroughly over all surfaces of both hands for 15 sec.

    Rinse with potable water.

  • Other Information:

    Store at 20 to 25 C (68-77 F)

  • Inactive ingredients:

    Water, Coco-Glucoside, Lautrimonoium Chloride, Cocamidopropylamine Oxide, Citric Acid.

  • PRINCIPAL DISPLAY PANEL

    Harbor

    HARBOR MIST E2 SANITIZING

    FOAM SOAP WITH BZK

    Manufactured for von Drehle Corporation I Hickory, NC 28601

    QUESTIONS?

    Call 800-438-3631 or visit us online at harbortowelandtissue.com.

    NSF

    Nonfood Compounds

    Program listed (E2)

    (Registration #000000)

    1

    PET

    Item #H700E2

    1250 ml (42 fl. oz.)

    Made in the U.S.A.

    container label

  • INGREDIENTS AND APPEARANCE
    HARBOR MIST E2 SANITIZING FOAM WITH BZK 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81792-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81792-004-011250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2021
    Labeler - Von Drehle Corporation (071054415)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(81792-004)