Malacetic Ultra Otic Cleanser: Product Information

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.

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.

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)

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.

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

SHAKE WELL BEFORE USING

NDC 17033-142-08

MalAcetic ULTRA®

Otic Cleanser
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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg in 1 mL
Ketoconazole (Ketoconazole) Ketoconazole 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Propylene Glycol
ALCOHOL
GLYCERIN
Polysorbate 20
ACETIC ACID
CERAMIDE NP
CERAMIDE AP
CERAMIDE 1
PHYTOSPHINGOSINE
CHOLESTEROL
SODIUM LAUROYL LACTYLATE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17033-142-02 59 mL in 1 BOTTLE None
2 NDC:17033-142-08 236 mL in 1 BOTTLE None
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)

Revised: 11/2021 Dechra Veterinary Products

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