MALASEB- chlorhexidine gluconate, miconazole nitrate shampoo 
Bayer HealthCare LLC

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 Shampoo

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.

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 (2% Clorihexidine Gluconate, 2% Miconazole Nitrate) label

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)

MALASEB 
chlorhexidine gluconate, miconazole nitrate shampoo
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0859-3016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 g  in 1 L
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 g  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0859-3016-051.89 L in 1 BOTTLE, PLASTIC
2NDC:0859-3016-030.237 L in 1 BOTTLE, PLASTIC
3NDC:0859-3016-060.473 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/09/201407/01/2022
Labeler - Bayer HealthCare LLC (152266193)

Revised: 6/2022
 
Bayer HealthCare LLC