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Nitrozone

Generic Name: nitrofurazone
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 Item Code (Source) NDC: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
Packaging
# Item Code Package Description
1 NDC:64556-900-01 453.6 g in 1 JAR
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: 12/2009
 
First Companion Veterinary Products



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