Label: MALASEB- chlorhexidine gluconate and miconazole nitrate shampoo

  • NDC Code(s): 17033-185-08, 17033-185-16
  • 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 May 2, 2024

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  • VETERINARY INDICATIONS

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

    The fragrance-free shampoo base descales and degreases the hair coat without stripping.

  • DESCRIPTION

    Active Ingredients: 2% Chlorhexidine Gluconate, USP; 2% Miconazole Nitrate, USP

    Also Contains: Water, Decyl Polyglucoside, Cetrimonium Chloride, Laureth-12, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Acetic Acid

  • DOSAGE & ADMINISTRATION

    Directions for Use: SHAKE WELL BEFORE EACH USE. Wet coat thoroughly with water. Apply and lather shampoo over entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Use weekly or as directed by your veterinarian.

  • PRECAUTIONS

    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.

  • SAFE HANDLING WARNING

    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. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Available through licensed veterinarians.

    For Veterinary Use Only.

  • SPL UNCLASSIFIED SECTION

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

    www.dechra-us.com

    Malaseb® is a registered
    trademark of Dermcare-Vet Pty. Ltd.

    MALSHAM-16 REV08/23-V

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    SHAKE WELL BEFORE USING

    Malaseb®
    Shampoo
    2% Chlorhexidine Gluconate, USP
    2% Miconazole Nitrate, USP
    Formulated for dogs, cats
    and horses
    Antimicrobial, antifungal

    16 fl. oz.
    (473 mL)

    Dechra

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MALASEB 
    chlorhexidine gluconate and miconazole nitrate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-185-08236 mL in 1 BOTTLE
    2NDC:17033-185-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other09/01/2022
    Labeler - Dechra Veterinary Products (362142734)
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