Label: ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH- ketoconazole solution

  • NDC Code(s): 86175-005-12, 86175-005-24
  • Packager: Alpha Paw Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Ketoconazole...............................................0.1%

  • PURPOSE

    ANTIBACTERIAL & ANTIFUNGAL MEDICATED TRIS FLUSH For Dogs & Cats

  • FIGHT FUNGUS!

    Say goodbye to pesky ear infections. Treatment is as easy as point, squeeze and soothe. Skin conditions that are responsive to Ketoconazole stand no chance against this powerful formula. Non-irritating formula ensures pets are comfortable.

  • INACTIVE INGREDIENTS

    Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.

  • PRECAUTIONS

    For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

  • DIRECTIONS

    Shake well before use. Apply liberally to the affected area(s). Apply twice daily or as directed by veterinarian. Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion. Wash hands after use.

  • STORAGE

    Store at controlled room temperature; protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Contains ketoconazole
    Manages fungal activity
    Gentle flushing of ears & skin
    Antiseptic & antifungal solution

    GENTLE ON SKIN
    CHOSEN BY TOP VETS
    FOR DOGS AND CATS

    ALPHA PAW
    Questions or Comments:
    Call (800) 363-5458
    www.alphapaw.com
    Alpha Paw LLC, Las Vegas NV 89139

  • Packaging

    Package 12oz 355mL

    Package 12oz 355mL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH 
    ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86175-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86175-005-12355 mL in 1 CONTAINER
    2NDC:86175-005-241 in 1 PACKAGE
    2355 mL in 1 CONTAINER; Number of Units = 2
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/03/2022
    Labeler - Alpha Paw Inc (117036685)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropichem Research Labs, LLC dba Vetio603123068manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Piramal Pharma Limited919067108api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharon Bio-Medicine Limited675472749api manufacture
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