KC Oto-Pack: Product Information

KC OTO-PACK- hydrocortisone and 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.

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
(click image for full-size original)
KC OTO-PACK
hydrocortisone, ketoconazole gel
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86002-103
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 1000 mL
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 0.15 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLOXAMER 407
PROPYLENE GLYCOL
GLYCOLIC ACID
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86002-103-02 54 mL in 1 CONTAINER None
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)

Revised: 03/2015 DermaZoo, LLC

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