Malaseb by Bayer HealthCare, LLC Animal Health Division Malaseb® Spray

Malaseb by

Drug Labeling and Warnings

Malaseb by is a Animal medication manufactured, distributed, or labeled by Bayer HealthCare, LLC Animal Health Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MALASEB- chlorhexidine gluconate, miconazole spray 
Bayer HealthCare, LLC Animal Health Division

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.

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Malaseb® Spray

 

Topical spray formulation for dogs, cats and horses

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

KEY INGREDIENTS:

Miconazole 1.74% w/v (equivalent to 2% w/v Miconazole Nitrate), Chlorhexidine Gluconate 2% w/v. Also contains Alcohol 30% w/v.

PRODUCT DESCRIPTION:

Malaseb Spray combines miconazole nitrate and chlorhexidine gluconate with the benefits of essential fatty acids and Vitamin E for skin barrier support and hydration.

INDICATIONS:

For skin conditions responsive to miconazole nitrate and chlorhexidine gluconate. A convenient spray for easy spot application.

DIRECTIONS:

Use in a well-ventilated area. Spray directly on the affected area(s) 2 to 3 times daily, as directed by your veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion.

CAUTIONS:

For topical use on dogs, cats and horses. Do not allow animal to directly inhale the spray. Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and consult your veterinarian.

STORAGE:

Store at room temperature. Protect from freezing. Keep away from extreme heat or flame.

Manufactured for

Bayer HealthCare LLC, Animal Health Division Shawnee Mission, KS 66201

Made in Canada

Bayer, the Bayer Cross and DVM & Design are registered trademarks of Bayer.

Malaseb is a registered trademark of Dermcare-Vet Pty. Ltd.

© 2019 Bayer

LV1909

Package/Label Principal Display Panel

Malaseb®

Spray

Topical spray formulation for dogs, cats and horses

2% w/v Chlorhexidine Gluconate

2% Miconazole Nitrate

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: Keep out of reach of children. | Topical Spray

NET CONTENTS: 237 mL (8 fl oz)

MALASEB 
chlorhexidine gluconate, miconazole spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0859-2402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	0.021 mg  in 1 mL
MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE	0.017 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0859-2402-01	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/10/2020	07/01/2022

Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)

Revised: 6/2022

Document Id: 1a62be02-966b-48da-9ad0-0e7feb62022d

50578-4

Set id: 1f4356c7-689b-4876-b92c-e3785b77492c

Version: 3

Effective Time: 20220621

 

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