Label: FRISCO ANTISEPTIC EAR FLUSH- ketoconazole liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 27, 2020

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  • ACTIVE INGREDIENTS:

    Ketoconazole 0.1% w/v.

  • PURPOSE

    Antibacterial & Antifungal Solution

  • INDICATIONS & USAGE

    Medicated cleansing and flushing solution to support topical conditions responsive to Ketoconazole.

  • CAUTIONS:

    For topical use in animals only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and get medical attention if irritation persists. If skin irritation persists or increases, discontinue use and contact your veterinarian. DO NOT USE ON BURNS, PUNCTURE WOUNDS, LACERATIONS, OR RUPTURED MEMBRANES.

    Keep out of the reach of children and pets.

  • DIRECTIONS FOR USE:

    Shake well before use. Apply liberally to the affected area(s). Apply twice daily or as directed by a veterinarian. Use cotton or other absorbent material to clean excess solution and wipe away debris. Store at controlled room temperature. Protect from freezing.

  • OTHER INGREDIENTS:

    Water, Isopropanol, Nonoxynol-9, Benzyl Alcohol, Disodium EDTA, Fragrance, Tromethane.

  • SPL UNCLASSIFIED SECTION

    FOR DOGS, CATS & HORSES

    Distributed by Chewy, INC.
    Dania Beach, FL 33004
    1-800-672-4399

    Manufactured in the USA with globally sourced ingredients | SKU 178705-1

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    FRISCO ANTISEPTIC EAR FLUSH 
    ketoconazole liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86109-735
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86109-735-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/27/2020
    Labeler - Chewy, Inc. (078790269)
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Safety

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