Label: KC OTO-PACK- hydrocortisone, ketoconazole gel

  • Category: PRESCRIPTION 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 March 20, 2015

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  • INDICATIONS AND USAGE

    PRE-USE: Prior to applying KC Oto-Pack™, after examining the dog or cat, and preferably doing cytology, clean and dry the ear canal using GlycoZoo™ Otic.

    DIRECTIONS: Shake or stir well, then draw 2-5 mL or more of KC Oto-Pack, depending upon size of pet, into a clean (feeding) syringe. Insert tip of syringe into ear canal and apply product by pushing the plunger. KC Oto-Pack will begin to thicken as it warms to the pet’s body temperature. Rub ears and prevent head shaking for about a minute to allow product to settle into ear canal and totally thicken. Take precautions to avoid introduction of contaminants.

    KC Oto-Pack aids in the treatment of otitis externa and ear itching due to yeast infections, and does not need to be removed. Reapply as needed every 7 days.

  • WARNINGS AND PRECAUTIONS

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Avoid contact with eyes. For dog and cat topical use only. Keep out of reach of children. See insert for more information.

  • DESCRIPTION

    ACTIVE INGREDIENTS: 1.0% Hydrocortisone, 0.15% Ketoconazole

    INACTIVE INGREDIENTS: Water, Poloxamer 407, Propylene Glycol, Gycolic Acid, Iodopropynyl Butylcarbamate

  • STORAGE CONDITIONS

    STORE THIS SIDE UP

    STORE AT ROOM TEMPERATURE

    After opening container, discard contents after 90 days.

  • KC Oto-Pack™

    THERMALLY ACTIVATED GEL

    Hydrocortisone

    Ketoconazole

    FOR DOGS & CATS

    Net Contents: 2 oz. (54 ml)

    Made in USA

    Manufactured for:  DermaZoo™ Pharma, www.dermazoo.com, info@dermazoo.com

    20150306 103 KC Oto

  • INGREDIENTS AND APPEARANCE
    KC OTO-PACK 
    hydrocortisone, ketoconazole gel
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86002-103
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 1000 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.15 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86002-103-0254 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2015
    Labeler - DermaZoo, LLC (969506752)
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