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

Drug Details [pdf]

MALASEB FLUSH- chlorhexidine gluconate, miconazole solution
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® FLUSH

A topical formulation containing Chlorhexidine Gluconate (0.2%) and Miconazole Nitrate (0.2) 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 base 0.174% w/v (equivalent to Miconazole Nitrate 0.2% w/v), Chlorhexidine Gluconate 0.2% w/v.

PRODUCT DESCRIPTION:

Malaseb® Flush combines a unique water-based formulation of multifunctional surfactants for effective, gentle cleansing.

INDICATIONS:

For dermatological conditions responsive to miconazole nitrate and chlorhexidine gluconate as recommended by your veterinarian.

DIRECTIONS:

Apply Malaseb® Flush liberally to affected area. Use cotton or absorbent material to clean excess solution. Do not allow animal to lick the treated areas until dry to prevent ingestion. Wash hands after use. Apply twice daily 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 consult your veterinarian. Safe use of the product in ears has not been evaluated.

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.

90197486

LV2011

Principal Display Panel – 118 mL Bottle Label

Elanco™

Malaseb®

FLUSH

A topical formulation containing
Chlorhexidine Gluconate (0.2%)
and Miconazole Nitrate (0.2%)
for Dogs, Cats and Horses.

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

NET CONTENTS 118 mL (4 fl oz)

Principal Display Panel – 118 mL Bottle Label

MALASEB FLUSH
chlorhexidine gluconate, miconazole solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58198-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)	Chlorhexidine Gluconate	11.53 mg in 1 mL
Miconazole (UNII: 7NNO0D7S5M) (Miconazole - UNII:7NNO0D7S5M)	Miconazole	1.710 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
LAURETH-12 (UNII: OAH19558U1)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
ACETIC ACID (UNII: Q40Q9N063P)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC: 58198-0011-1	1 in 1 BOTTLE, PLASTIC
1		118 mL in 1 BOTTLE, PLASTIC
2	NDC: 58198-0011-2	1 in 1 BOTTLE, PLASTIC
2		355 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		09/15/2014	09/30/2022

Labeler - Elanco US Inc. (966985624)

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

Name	Address	ID/FEI	Business Operations
Establishment
Yung Zip Chemical Industrial Co., Ltd.		656123205	API MANUFACTURE

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

Revised: 9/2022

Document Id: cc344107-7c4b-489d-b749-a798ea471319

Set id: 18dbe87a-f9e0-4d3e-aab9-864b8e088ae5

Version: 2

Effective Time: 20220930