MALASEB- chlorhexidine gluconate, miconazole nitrate shampoo

Malaseb by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

KEY INGREDIENTS:

Miconazole Nitrate 2%, Chlorhexidine Gluconate 2%.

PRODUCT DESCRIPTION:

Malaseb® Shampoo combines a unique formulation of chlorhexidine gluconate and miconazole nitrate with coat conditioners. The fragrance-free shampoo base descales and degreases the hair coat without stripping.

INDICATIONS:

For dermatological conditions responsive to miconazole nitrate and chlorhexidine gluconate.

DIRECTIONS:

Wet coat thoroughly with water. Apply and lather Malaseb® Shampoo over the entire body, allowing 10 minutes of contact time. Rinse completely with water. Do not allow animal to lick while bathing to prevent ingestion. Use weekly or as directed by your veterinarian.

CAUTIONS:

For topical use on dogs, cats and horses. Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian.

STORAGE:

Store at room temperature. Protect from freezing.

SPL UNCLASSIFIED SECTION

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 LV1908

Package/Label Principal Display Panel

Malaseb®
Shampoo

Shampoo Formulation
for Dogs, Cats and Horses

2% 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. | Shampoo

NET CONTENTS: 237 mL (8 fl oz)

INGREDIENTS AND APPEARANCE

MALASEB 
chlorhexidine gluconate, miconazole nitrate shampoo

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 0859-3016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 g  in 1 L
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 g  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0859-3016-05	1.89 L in 1 BOTTLE, PLASTIC
2	NDC: 0859-3016-03	0.237 L in 1 BOTTLE, PLASTIC
3	NDC: 0859-3016-04	0.355 L in 1 BOTTLE, PLASTIC
4	NDC: 0859-3016-06	0.473 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/09/2014

Labeler - Bayer HealthCare LLC (152266193)