ZOONO WOUND CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [ZOONO USA, LLC]

ZOONO WOUND CLEANSER (BENZALKONIUM CHLORIDE) SOLUTION [ZOONO USA, LLC]
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NDC 69221-204-01, 69221-204-02, 69221-204-03
Set ID 41fae81e-a2f5-1c07-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager ZOONO USA, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose:

    Antiseptic

  • Uses:

    Helps protect skin and supports healing

    of minor cuts, scrapes, burns and wounds,

    including pressure sores, diabetic ulcers,

    cracked skin and lips. Topical antiseptic to help

    decrease the risk of skin infections.

  • Warnings:

    For external use only.

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with

    eyes. In case of eye contact flush eyes with

    water. Stop use and ask a doctor if condition

    worsens, symptoms last more than 7 days or

    clear up and occur again within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a

    Poison Control Center right away.

  • Inactive Ingredients:

    Ethyl alcohol,

    Fragrances, Silica Complex

    3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl

    Ammonium Chloride), Water.

  • Questions or Comments?

    Telephone 1-844-966-6687

    Monday through Friday

    8:00am till 5:00pm EST

  • Directions:

    Wound cleansing for adults and children 2

    years of age or older: Spray the affected area

    to clean dirt and debris, use a small amount of

    the product and wipe it off with a sterile gauze.

    For use as First Aid antiseptic for adults and

    children years of age or older:

    Clean the affected area. Spray a small amount of

    this product on the area 1 to 3 times daily or as

    needed. Wipe off excess with sterile gauze and

    allow to dry. Cover affected area with a sterile

    bandage if needed. When bandaged, let dry first

    For children under 2 years of age please

    consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    typical of all sizes

  • INGREDIENTS AND APPEARANCE
    ZOONO WOUND CLEANSER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69221-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69221-204-02150 mL in 1 BOTTLE; Type 0: Not a Combination Product11/23/2016
    2NDC:69221-204-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product11/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/23/2016
    Labeler - ZOONO USA, LLC (073623478)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zoono USA, LLC073623478label(69221-204)

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