Nitrozone

Dosage Form: FOR ANIMAL USE ONLY
Nitrozone Soluble Dressing (nitrofurazone) First Companion Veterinary Products NADA 122-447, Approved by FDA

Indications

For the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers.  For use only on dogs, cats and horses.

Administration

Apply directly on the lesion with a spatula or first place on a piece of gauze.  Application of a bandage is optional.

This preparation should be in contact with the lesion for at least 24 hours.  The dressing may be changed several times daily or left on the lesion for a longer period.

Caution

In case of deep or puncture wounds or serious burns, consult a veterinarian.  If redness, irritation or swelling persists or increase, discontinue use and consult a veterinarian.

Avoid exposure to excessive heat or direct sunlight and strong fluorescent lighting.

Human Warnings: Carcinogenesis

Nitrofurazone, the active ingredient of Nitrozone Dressing has been shown to produce mammary tumors in rats and ovarian tumors in mice.

Additionally, some people may be hypersensitive to this product.  Either wear gloves when applying, or wash hands afterwards.

Not to be used on animals intended for food purposes.

Storage and Handling

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F); excursions permited to 15 degrees to 30 degrees C (59 degrees to 86 degrees F)

(See USP Controlled Room Temperature)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Package Label Display Panel

Nitrozone

(Brand of Nitrofurazone Soluble Dressing)

FOR USE ONLY ON DOGS, CATS AND HORSES

WARNING:  DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUPTION.

AN ANTIBACTERIAL PREPARATION FOR TOPICAL APPLICATION

Federal law prohibits the extralabel use of this drug in food-producing animals.

CONTENTS:  0.2% Nitrofurazone in a Water Soluble base of Polyethylene Glycols.

NADA 122-447, Approved by FDA

Net Weight:  1 Pound

Nitrozone  nitrofurazone  dressing

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 64556-900 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nitrofurazone (Nitrofurazone) Nitrofurazone 0.907 g  in 453.6 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64556-900-01 453.6 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA122447	10/01/2009

Labeler - First Companion Veterinary Products (059580480)

Revised: 12/2009First Companion Veterinary Products