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Animal NDC 17033-186-08 Malaseb

Chlorhexidine Gluconate And Miconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 17033-186-08
Proprietary Name Malaseb What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Chlorhexidine Gluconate And Miconazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Dechra Veterinary Products
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Chlorhexidine Gluconate
  • Miconazole Nitrate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Malaseb Images

Malaseb Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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 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.

Spray directly onto the affected area(s) 2 - 3 times daily or as directed by your veterinarian. 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.


Other



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
Malaseb® is a registered
trademark of Dermcare-Vet Pty. Ltd.
MALSPRAY-8 REV11/24-V


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.