MAL-A-KET- chlorhexidine gluconate, acetic acid, and ketoconazole solution

Mal-A-Ket by

Drug Labeling and Warnings

Mal-A-Ket by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products, Tropichem, Lab Express International, Eastman Chemical Company, Nanjing Baijingyu Pharmaceutical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

For support of healthy skin for animals with conditions responsive to ketoconazole and/or chlorhexidine.

DESCRIPTION

Active Ingredients: 2% Chlorhexidine Gluconate, USP; 1% Ketoconazole, USP

Also Contains: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Acetic Acid, Decyl Glucoside, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone

DOSAGE & ADMINISTRATION

Directions for Use: SHAKE WELL BEFORE EACH USE. Apply to wet coat, rub onto skin and haircoat to create a rich lather. Allow shampoo to remain on skin and coat for 5-10 minutes. Rinse well. Use initially 2-4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian.

SAFE HANDLING WARNING

Caution: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets.

WARNINGS

Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

STORAGE AND HANDLING

Store at room temperature.

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians.

Made in the USA.

MKW REV03/19

Manufactured for:
Dechra Veterinary Products
7015 College Blvd.,
Overland Park, KS 66211
www.dechra-us.com
(866) 933-2472

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

MAL-A-KET Shampoo

SHAKE WELL BEFORE USING

NDC: 17033-132-08

MAL-A-KET®
Shampoo

Formulated for dogs, cats and
horses

Antimicrobial, antifungal

U.S. Patent
9,345,674

8 fl. oz.
(236 mL)

Dechra

INGREDIENTS AND APPEARANCE

MAL-A-KET 
chlorhexidine gluconate, acetic acid, and ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-132-01	3785 mL in 1 BOTTLE
2	NDC: 17033-132-08	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/01/2012

Labeler - Dechra Veterinary Products (362142734)

Establishment
Name	Address	ID/FEI	Business Operations
Unilab Chemical and Pharmaceuticals Private Limited		915893696	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Enterprises Limited		919067108	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medical		918572723	API MANUFACTURE