Label: MALACETIC ULTRA CONDITIONER- hydrocortisone and ketoconazole spray

  • NDC Code(s): 17033-162-08
  • Packager: Dechra Veterinary Products
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated April 14, 2021

If you are a consumer or patient please visit this version.

  • VETERINARY INDICATIONS

    For support of healthy skin for animals with bacterial and/or fungal skin conditions. Hydrocortisone helps promote relief of itchy skin. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

  • DESCRIPTION

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

  • SPL UNCLASSIFIED SECTION

    Also Contains: Water, Propylene Glycol, SD Alcohol 40-B, Glycerine, Boric Acid, Polysorbate 20, Acetic Acid, PEG-75 Lanolin, Sodium Lactate, Fragrance, Decolorized Aloe Vera, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum), Methylisothiazolinone

  • DOSAGE & ADMINISTRATION

    Directions for Use: SHAKE WELL BEFORE EACH USE. For dry application - apply directly to skin and haircoat and allow to dry. For wet application or after shampooing - remove excess moisture and apply directly to skin and haircoat. Use as often as desired or as directed by veterinarian.

  • SAFE HANDLING WARNING

    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 controlled room temperature of 20 - 25° C (68 - 77° F).

  • SPL UNCLASSIFIED SECTION

    Available through licensed veterinarians only.

    Made in the USA.

    MUCW REV02/19

    Manufactured for:
    Dechra Veterinary Products
    7015 College Blvd.,
    Overland Park, KS 66211
    www.dechra-us.com
    (866) 933-2472

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    SHAKE WELL BEFORE USING

    NDC 17033-162-08

    MALACETIC ULTRA®

    Spray Conditioner

    Formulated for dogs, cats and horses

    Antipruritic, antimicrobial,
    anti-inflammatory, moisturizing

    U.S. Patent 8,722,102

    8 fl. oz.
    (236 mL)

    Dechra

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MALACETIC ULTRA CONDITIONER 
    hydrocortisone and ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-162
    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:17033-162-08236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2016
    Labeler - Dechra Veterinary Products (362142734)