Label: MAL-A-KET- chlorhexidine gluconate, acetic acid, and ketoconazole solution

  • NDC Code(s): 17033-132-01, 17033-132-08
  • 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 February 26, 2021

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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, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Acetic Acid, Decyl Glucoside, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, 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.

    Made in the USA.

    Manufactured for:
    Dechra Veterinary Products
    7015 College Blvd.,
    Overland Park, KS 66211
    866.933.2472

    MKW REV10/20

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    SHAKE WELL BEFORE USING

    NDC 17033-132-08

    Mal-A-Ket®
    Shampoo
    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, acetic acid, and ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID20 mg  in 1 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-132-013785 mL in 1 BOTTLE
    2NDC:17033-132-08236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/01/2012
    Labeler - Dechra Veterinary Products (362142734)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilab Chemical and Pharmaceuticals Private Limited915893696API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Piramal Enterprises Limited919067108API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Sharon Bio-Medical Limited675472749API MANUFACTURE
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