Label: MALASEB- chlorhexidine gluconate and miconazole spray

  • NDC Code(s): 17033-186-08
  • 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 September 12, 2022

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

  • VETERINARY INDICATIONS

    For support of healthy skin for animals with conditions responsive to miconazole and/or chlorhexidine. Essential fatty acids and Vitamin E provides skin barrier support and hydration.

  • DESCRIPTION

    Active Ingredients: 2% w/v Chlorhexidine Gluconate, USP; 1.74% w/v Miconazole, USP (equivalent to 2% w/v Miconazole Nitrate)

    Also Contains: Propylene Glycol, SD Alcohol 3-C, Sodium Coco PG-Dimonium Chloride Phosphate, Acetic Acid, d-Alpha Tocopheryl Polyethylene Glycol Succinate, Linoleamidopropyl PG-Dimonium Chloride Phosphate

  • DOSAGE & ADMINISTRATION

    Directions for Use: Use in a well-ventilated area. Spray directly onto the affected area(s) 2 - 3 times daily or as directed by your veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion. All changes (positive or negative) in the condition of the skin and haircoat should be reported to your veterinarian to determine continued use of this spray.

  • 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. Keep away from extreme heat or flame.

  • 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.
    MALSPRAY-8
    REV05/22

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    SHAKE WELL BEFORE USING

    Malaseb®
    Spray
    2% w/v Chlorhexidine Gluconate, USP
    2% w/v Miconazole Nitrate, USP
    Formulated for dogs, cats and horses
    Antimicrobial, antifungal

    8 fl. oz. (236 mL)

    Dechra

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MALASEB 
    chlorhexidine gluconate and miconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-186
    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 (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-186-08236 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)