Label: MAL-A-KET- chlorhexidine gluconate and ketoconazole shampoo, suspension

  • NDC Code(s): 17033-131-01, 17033-131-08
  • Packager: Dechra Veterinary Products
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 12, 2023

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  • VETERINARY INDICATIONS

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

  • DESCRIPTION

    Active Ingredients: 2% Chlorhexidine Gluconate, USP; 1% Ketoconazole, USP

    Also Contains: Water, Lauramine Oxide, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Decyl Polyglucoside, Acetic Acid, Fragrance, Sodium Hydroxide, Tetrasodium EDTA, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone

  • DOSAGE & ADMINISTRATION

    Directions for Use: SHAKE WELL BEFORE EACH USE. Apply to wet coat, rub onto skin and haircoat to create a rich lather. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use initially 2-4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian.

  • 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

    MKW REV08/23-C

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    SHAKE WELL BEFORE USING

    Mal-A-Ket®

    Shampoo
    2% Chlorhexidine Gluconate, USP
    1% Ketoconazole, USP

    Formulated for dogs, cats
    and horses

    Antimicrobial, antifungal

    U.S. Patent
    9,345,674

    8 fl. oz. (236 mL)

    Dechra

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAL-A-KET 
    chlorhexidine gluconate and ketoconazole shampoo, suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-131-08236 mL in 1 BOTTLE
    2NDC:17033-131-013785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/01/2023
    Labeler - Dechra Veterinary Products (362142734)
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