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Animal NDC 17033-143-08 Malacetic Ultra Otic Cleanser

Hydrocortisone And Ketoconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 17033-143-08
Proprietary Name Malacetic Ultra Otic Cleanser What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hydrocortisone And Ketoconazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Dechra Veterinary Products
Product Type Otc Animal Drug
Usage Information
    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 Ingredient(s)
  • Ketoconazole
  • Hydrocortisone
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Malacetic Ultra Otic Cleanser Images

Malacetic Ultra Otic Cleanser Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Veterinary Indications



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.


Description



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)


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.


Other



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 REV08/23-C


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.