MAL-A-KET PLUS TRIZEDTA FLUSH- chlorhexidine gluconate and ketoconazole solution

Mal-A-Ket Plus TrizEDTA Flush by

Drug Labeling and Warnings

Mal-A-Ket Plus TrizEDTA Flush by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. 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: 0.15% Chlorhexidine Gluconate, USP; 0.15% Ketoconazole, USP

Also Contains: Water, Glycerine, Nonoxynol-9, Glycolic Acid, TrizEDTA® (Tromethamine, USP; Disodium EDTA, USP), Decolorized Aloe Vera, Methylisothiazolinone

DOSAGE & ADMINISTRATION

Directions for Use: SHAKE WELL BEFORE EACH USE. For use as an ear flush: apply to the ear canal and gently, but firmly, massage the base of the ear. For use on skin: squeeze flush over affected area. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly.

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.

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

MKTW REV01/19

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

MAL-A-KET PLUS
TrizEDTA
Flush

SHAKE WELL BEFORE USING

NDC: 17033-191-04

MAL-A-KET® PLUS

TrizEDTA® Flush

Formulated for dogs and cats

Antimicrobial, antifungal, antibiofilm

U.S. Patent
6,538,155

4 fl. oz.
(118 mL)

Dechra

INGREDIENTS AND APPEARANCE

MAL-A-KET PLUS TRIZEDTA FLUSH 
chlorhexidine gluconate and ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	15 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
Nonoxynol-9 (UNII: 48Q180SH9T)
Glycolic Acid (UNII: 0WT12SX38S)
Tromethamine (UNII: 023C2WHX2V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-191-04	118 mL in 1 BOTTLE
2	NDC: 17033-191-12	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2016

Labeler - Dechra Veterinary Products (362142734)