Fura Septin

Generic Name: nitrofurazone

Dosage Form: FOR ANIMAL USE ONLY
Fura-Septin tm (Brand of Nitrofurazone Soluble Dressing) 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 veterinarian.  If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian.

Human Warnings: Carcinogenesis:  Nitrofurazone, the active ingredient of Fura-Septin 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.

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

Not to be used on animals intended for food purposes.

Store at 20deg - 25deg C (68deg - 77deg F); excursions permitted to 15deg - 30deg C (59deg - 86deg F)

(See USP Controlled Room Temperature).

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Fura-SeptinTM

(Brand of Nitrofurazone Soluble Dressing)

For use only on dogs, cats and horses

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

Warning:  Do not use on horses intended for human consumption

An antibacterial preparation topical application

Contents:  0.2% Nitrofurazone in a water soluble base of Polyethylene Glycols

NADA 122-447, Approved by FDA

Manufactured for:

Bimeda, Inc.

Le Sueur, MN 56058

FURA-SEPTIN  nitrofurazone  dressing

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 61133-7722 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nitrofurazone (Nitrofurazone) Nitrofurazone 0.9072 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 61133-7722-2 453.6 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 - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)

Revised: 09/2009Bimeda, Inc. Division of Cross Vetpharm Group