KC OTO-PACK- hydrocortisone, ketoconazole gel

KC Oto-Pack by

Drug Labeling and Warnings

KC Oto-Pack by is a Animal medication manufactured, distributed, or labeled by DermaZoo, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

KC OTO-PACK 
hydrocortisone, ketoconazole gel

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 86002-103
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 1000 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.15 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCOLIC ACID (UNII: 0WT12SX38S)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86002-103-02	54 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2015

Labeler - DermaZoo, LLC (969506752)