KC OTO-PACK- hydrocortisone, ketoconazole gel 
DermaZoo, LLC

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.

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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

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)

Revised: 3/2015
Document Id: 8851cc85-9ab6-4a26-a451-c4101ea1b9fa
Set id: 9c0c5b19-a6fb-434e-a319-eba1d9b04cf1
Version: 1
Effective Time: 20150320
 
DermaZoo, LLC