Malaseb by Elanco US Inc. / Lab Express International / Yung Zip Chemical Industrial Co., Ltd. / Tropichem Research Labs, LLC dba Vetio Malaseb® SPRAY

Malaseb by

Drug Labeling and Warnings

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

Drug Details [pdf]

MALASEB- chlorhexidine gluconate, miconazole spray 
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® 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 immediately consult your veterinarian.

STORAGE:

Store at room temperature. Protect from freezing.

Keep away from extreme heat or flame.

Manufactured for Elanco US Inc.

Shawnee, KS 66216

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

© 2020 Elanco or its affiliates

Principal Display Panel – 237 mL Bottle Label

Elanco™

Malaseb®

SPRAY

Topical spray formulation
for dogs, cats and horses

2% w/v Chlorhexidine Gluconate

2% w/v 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: 58198-0010
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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
ALCOHOL (UNII: 3K9958V90M)
ACETIC ACID (UNII: Q40Q9N063P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58198-0010-1	1 in 1 BOTTLE, SPRAY
1		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	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
Yung Zip Chemical Industrial Co., Ltd.		656123205	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: 2ddfee1e-0673-4a07-a3a6-7eb6925af6ac

50578-4

Set id: aa4e8172-5e2f-42dc-a9bc-ec212a0093c0

Version: 2

Effective Time: 20220930