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 December 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- VETERINARY INDICATIONS
-
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
- SAFE HANDLING WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
MALASEB
chlorhexidine gluconate and miconazole sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17033-186 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) Miconazole Nitrate 20 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17033-186-08 236 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 09/01/2022 Labeler - Dechra Veterinary Products (362142734)