MALACETIC ULTRA OTIC CLEANSER- hydrocortisone and ketoconazole liquid 
Dechra Veterinary Products

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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Malacetic Ultra® Otic Cleanser

For ear cleaning and use as a drying agent in dogs, cats and horses with conditions responsive to hydrocortisone and ketoconazole. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

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

Also Contains: Propylene Glycol, SDA 40B Ethanol, Glycerin, Polysorbate 20, Acetic Acid, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide I, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum)

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.

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.

Store at room temperature.

Available through licensed veterinarians.

For Veterinary Use Only.

Manufactured for:
Dechra Veterinary Products
7015 College Blvd.
Overland Park, KS 66211
866.933.2472
www.dechra-us.com

8MUW REV01/23

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

SHAKE WELL BEFORE USING

MalAcetic ULTRA®

Otic Cleanser
1% Hydrocortisone, USP
0.15% Ketoconazole, USP
Formulated for dogs, cats
and horses
Cleansing, drying,
anti-inflammatory,
antimicrobial, antifungal

8 fl. oz. (236 mL)

Dechra

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
MALACETIC ULTRA OTIC CLEANSER 
hydrocortisone and ketoconazole liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 mL
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole1.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17033-143-0259 mL in 1 BOTTLE
2NDC:17033-143-08236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/23/2023
Labeler - Dechra Veterinary Products (362142734)

Revised: 6/2023
Document Id: f5e14079-cde7-4d81-9434-f2ec606a3535
Set id: be213df7-1fef-43a7-a6d6-d9bb0c48a150
Version: 1
Effective Time: 20230608
 
Dechra Veterinary Products