MALACETIC ULTRA OTIC CLEANSER- hydrocortisone and ketoconazole liquid

Malacetic Ultra Otic Cleanser by

Drug Labeling and Warnings

Malacetic Ultra Otic Cleanser 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 ear cleaning and use as a drying agent in dogs, cats and horses with inflamed and infected ears due to bacteria and/or fungi (yeast). Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION

Active Ingredients: 1% Hydrocortisone, USP; 0.15% Ketoconazole, USP

Also Contains: Propylene Glycol, SD Alcohol 40-B, Glycerine, Polysorbate 20, Acetic Acid, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum)

DOSAGE & ADMINISTRATION

Directions for Use: SHAKE WELL BEFORE EACH USE. Apply to the ear canal and gently, but firmly, massage the base of the ear. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly.

WARNINGS

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. Wash hands after use.

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

8MUW REV04/19

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

MALACETIC ULTRA Otic Cleanser

SHAKE WELL BEFORE USING

NDC: 17033-142-08

MALACETIC ULTRA®
Otic Cleanser

Formulated for dogs, cats
and horses

New Fragrance Free Formula

Cleansing, drying,
anti-inflammatory,
antimicrobial, antifungal

8 fl. oz.
(236 mL)

Dechra

INGREDIENTS AND APPEARANCE

MALACETIC ULTRA OTIC CLEANSER 
hydrocortisone and ketoconazole liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 mL
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
Polysorbate 20 (UNII: 7T1F30V5YH)
ACETIC ACID (UNII: Q40Q9N063P)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-142-02	59 mL in 1 BOTTLE
2	NDC: 17033-142-08	236 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)