KC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]

KC OTO-PACK (HYDROCORTISONE, KETOCONAZOLE) GEL [DERMAZOO, LLC]
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NDC 86002-103-02
Set ID 9c0c5b19-a6fb-434e-a319-eba1d9b04cf1
Category PRESCRIPTION ANIMAL DRUG LABEL
Packager DermaZoo, LLC
Generic Name
Product Class
Product Number
Application Number
  • 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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