Label: MAL-A-KET PLUS TRIZEDTA FLUSH- chlorhexidine gluconate and ketoconazole solution

  • NDC Code(s): 17033-193-04, 17033-193-12
  • Packager: Dechra Veterinary Products, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 12, 2024

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  • VETERINARY INDICATIONS

    For support of healthy skin for animals with conditions responsive to ketoconazole and/or chlorhexidine.

  • DESCRIPTION

    Active Ingredients: 0.15% Chlorhexidine Gluconate, USP; 0.15% Ketoconazole, USP

    Also Contains: Water, Nonoxynol-9, Glycerin, Glycolic Acid, TrizEDTA® (Tromethamine, USP; Disodium EDTA), Methylisothiazolinone, Aloe Vera Gel

  • DOSAGE & ADMINISTRATION

    Directions for Use: SHAKE WELL BEFORE EACH USE. For use as an ear flush: apply to the ear canal and gently, but firmly, massage the base of the ear. For use on skin: squeeze flush over affected area. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly.

  • SAFE HANDLING WARNING

    Caution: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets.

  • WARNINGS

    Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

  • STORAGE AND HANDLING

    Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    Available through licensed veterinarians.

    For Veterinary Use Only.

    Manufactured for:
    Dechra Veterinary Products
    7015 College Blvd.
    Overland Park, KS 66211
    (866) 933-2472
    www.dechra-us.com

    12MKTW REV11/24-C

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    SHAKE WELL BEFORE USING

    Mal-A-Ket® Plus

    TrizEDTA® Flush
    0.15% Chlorhexidine Gluconate, USP
    0.15% Ketoconazole, USP
    Formulated for dogs and cats
    Antimicrobial, antifungal, antibiofilm

    12 fl. oz.
    (355 mL)
    Dechra

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAL-A-KET PLUS TRIZEDTA FLUSH 
    chlorhexidine gluconate and ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate1.5 mg  in 1 mL
    Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole1.5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-193-04118 mL in 1 BOTTLE
    2NDC:17033-193-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other12/10/2024
    Labeler - Dechra Veterinary Products, LLC (362142734)
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