Label: F10- f10 antiseptic solution concentrate liquid

  • NDC Code(s): 86152-0071-2
  • Packager: Health and Hygiene (Pty) Ltd
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Legally Marketed Unapproved New Animal Drugs for Minor Species

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Drug Label Information

Updated January 28, 2022

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  • Warnings

    Not for use in humans.  Keep out of reach of children

  • Uses

    For the treatment and control of upper and lower respiratory tract diseases associated with bacterial, fungal, or viral organisms.

    For use as a topical antiseptic for surface wounds.

  • Direction of use

    The concentrate need to be diluted with distilled or saline solution 1:250 prior to use.

    Use for Nebulization, nasal and sinus flushing and surface wounds.

    See label for further instructions

  • Packaging label

    Front Panel

    US231-01 22 ANTISEPTIC SOLUTION CONCENTRATE -200ml- GENERIC FP.jpg

    Front Panel

  • Packaging Label

    Back Panel

    US231-01 22 ANTISEPTIC SOLUTION CONCENTRATE -200ml- GENERIC BP.jpg

    Back panel1

  • Packaging Label

    Back Panel 2

    US231-01 22 ANTISEPTIC SOLUTION CONCENTRATE -200ml- GENERIC BP2.jpg

    Back Panel 2

  • INGREDIENTS AND APPEARANCE
    F10 
    f10 antiseptic solution concentrate liquid
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86152-0071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5.4 g  in 100 mL
    BIGUANIDE (UNII: FB4Q52I9K2) (BIGUANIDE - UNII:FB4Q52I9K2) BIGUANIDE0.4 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86152-0071-2200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    legally marketed unapproved new animal drugs for minor speciesMIF90000711/16/2011
    Labeler - Health and Hygiene (Pty) Ltd (636762007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Hygiene (Pty) Ltd636762007manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Lonza Group AG480007517api manufacture
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Safety

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Clinical Trials, PubMed, Biochemical Data Summary

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