Label: MALASEB FLUSH- chlorhexidine gluconate and miconazole nitrate solution

  • NDC Code(s): 17033-187-04, 17033-187-12
  • Packager: Dechra Veterinary Products
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 12, 2024

If you are a consumer or patient please visit this version.

  • VETERINARY INDICATIONS

    For support of healthy skin for animals with conditions responsive to chlorhexidine and miconazole.

  • DESCRIPTION

    Active Ingredients: 0.2% w/v Chlorhexidine Gluconate, USP; 0.174% w/v Miconazole, USP (equivalent to 0.2% w/v Miconazole Nitrate)

    Also Contains: Water, Propylene Glycol, Decyl Polyglucoside, Laureth-12, Cetrimonium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Coco PG-Dimonium Chloride Phosphate, Acetic Acid, Sodium Hydroxide

  • DOSAGE & ADMINISTRATION

    Directions for Use: SHAKE WELL BEFORE EACH USE. Use in a ventilated area and prevent the animal from licking and ingesting the product during application or throughout the drying time, as it may lead to gastrointestinal or respiratory tract irritation.

    Apply flush liberally to affected area. Use cotton or absorbent material to clean excess solution. Wash hands after use. Apply twice daily 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.

    MALFLUSH-12 REV11/24-V

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    SHAKE WELL BEFORE USING

    Malaseb®
    Flush
    0.2% w/v Chlorhexidine Gluconate,
    USP
    0.2% w/v Miconazole Nitrate, USP
    Formulated for dogs, cats
    and horses
    Antimicrobial, antifungal

    12 fl. oz.
    (355 mL)

    Dechra

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MALASEB FLUSH 
    chlorhexidine gluconate and miconazole nitrate solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 1 mL
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-187-04118 mL in 1 BOTTLE
    2NDC:17033-187-12355 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)