Malaseb® SHAMPOO

Malaseb by

Drug Labeling and Warnings

Malaseb by is a Animal medication manufactured, distributed, or labeled by Elanco US Inc., Lab Express International, Guangzhou Hanpu Pharmaceutical Co Ltd, Tropichem Research Labs, LLC dba Vetio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MALASEB- chlorhexidine gluconate, miconazole nitrate shampoo 
Elanco US Inc.

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

Shampoo 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 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 Elanco US Inc.

Shawnee, KS 66216

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

©2020 Elanco or its affiliates.

90197572 LV2011

Principal Display Panel – 237 mL Bottle Label

Elanco™

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 Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58198-0012
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0012-1	1 in 1 BOTTLE, PLASTIC
1		0.237 L in 1 BOTTLE, PLASTIC
2	NDC: 58198-0012-2	1 in 1 BOTTLE, PLASTIC
2		0.473 L in 1 BOTTLE, PLASTIC
3	NDC: 58198-0012-3	1 in 1 BOTTLE, PLASTIC
3		1.89 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	09/30/2022

Labeler - Elanco US Inc. (966985624)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Express International		800875106	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Hanpu Pharmaceutical Co Ltd		654030428	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Tropichem Research Labs, LLC dba Vetio		603123068	MANUFACTURE, PACK, LABEL, ANALYSIS

Revised: 9/2022

Document Id: 864b0990-e68c-4965-870e-f5f1b67236e4

50578-4

Set id: f1530b42-78ac-4a6f-99a1-a4f39fd654b9

Version: 2

Effective Time: 20220930