Label: OTICETIC FLUSH, MEDICATED- hydrocortisone and ketoconazole solution

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 8, 2021

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  • VETERINARY INDICATIONS

    Oticetic Flush, Medicated is an ear cleanser and drying agent for dogs and cats with inflamed and infected ears due to bacteria and/or fungi (yeast). 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: Propylene Glycol, SD Alcohol 40-B, Glycerine, Polysorbate 20, Acetic Acid, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Apply to ear 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

    WARNING: Keep out of reach of children.

    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.

  • HOW SUPPLIED

    STORAGE: Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    Available through licensed veterinarians only.

    Manufactured for:
    GlenHaven
    18101 SE 6th Way
    Vancouver, WA 98683

    39598 REV03/19

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    NDC 70782-142-08

    GlenHaven™
    Therapeutics

    FRAGRANCE FREE
    NEW IMPROVED FORMULATION

    Oticetic Flush,
    Medicated

    Anti-inflammatory,
    antimicrobial

    Acetic acid,
    hydrocortisone &
    ketoconazole

    For Dog and Cat Use Only

    Net Contents: 8 FL OZ. (236 mL)

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    OTICETIC FLUSH, MEDICATED 
    hydrocortisone and ketoconazole solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:70782-142
    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:70782-142-08236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2016
    Labeler - GlenHaven LLC (002542300)
    Registrant - Dechra Veterinary Products (362142734)
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