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
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- Official Label (Printer Friendly)
- VETERINARY INDICATIONS
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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
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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
- SAFE HANDLING WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
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INGREDIENTS AND APPEARANCE
MALASEB FLUSH
chlorhexidine gluconate and miconazole nitrate solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17033-187 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 mg in 1 mL MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17033-187-04 118 mL in 1 BOTTLE 2 NDC:17033-187-12 355 mL in 1 BOTTLE 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)