Animal NDC 86002-103-02 Kc Oto-pack

Hydrocortisone, Ketoconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 86002-103-02
Proprietary Name Kc Oto-pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hydrocortisone, Ketoconazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Dermazoo, Llc
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Hydrocortisone
  • Ketoconazole
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • POLOXAMER 407 (TUF2IVW3M2)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GLYCOLIC ACID (0WT12SX38S)
  • IODOPROPYNYL BUTYLCARBAMATE (603P14DHEB)
  • WATER (059QF0KO0R)
  • POLOXAMER 407 (TUF2IVW3M2)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • GLYCOLIC ACID (0WT12SX38S)
  • IODOPROPYNYL BUTYLCARBAMATE (603P14DHEB)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Kc Oto-pack Images

Kc Oto-pack Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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, [email protected]


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.