Label: MALACETIC ULTRA OTIC CLEANSER- hydrocortisone and ketoconazole liquid

  • NDC Code(s): 17033-143-08
  • Packager: Dechra Veterinary Products
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 14, 2024

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  • 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.

  • SPL UNCLASSIFIED SECTION

    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

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    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:17033-143-08236 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)
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