Approval Date: May 11, 1990
I. GENERAL INFORMATION:
438 W. Arrow Highway, Unit 30
San Dimas, CA 91773
nitrofurazone soluble dressing
Nitrofurazone Soluble Dressing
II. INDICATIONS FOR USE:
For the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use).
III. DOSAGE FORM, ROUTE OF ADMINISTRATION, AND RECOMMENDED DOSAGE:
Soluble ointment for topical application
Apply directly on the lesion with a spatula or first place on a piece of gauze. Use of a bandage is optional. The preparation should remain on the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.
IV. ANIMAL EFFECTIVENESS AND SAFETY:
Nitrofurazone Ointment (Furacin Dressing Veterinary, NADA 6-475) was the subject of a review by the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group, the results of which were published in the Federal Register on January 19, 1979 (44 FR 4014). NAS/NRC concluded, and FDA concurred, that the product was "effective" for the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers. Due to concern for the safety of residues from food producing animals, FDA concluded that use of this and other NAS/NRC reviewed nitrofurazone topical products must be limited to dogs, cats, and horses (not intended for food use). The Federal Register publication, dated January 19, 1979 on Nitrofurazone Topical Preparations for use in non-food animals, states that applications providing for the effective conditions of use identified in that notice need not include data required by 21 CFR 514.111 to establish effectiveness of the drug for these uses.
Under Center for Veterinary Medicine policy, the principles of 21 CFR 320.22, providing for a waiver of the requirements for submission of evidence of in vivo bioavailability and bioequivalence, are applied to NAS/NRC topicals which have been found to be effective. Therefore, such data were neither required nor submitted.
V. HUMAN SAFETY:
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this NADA. The drug is approved for use only on dogs, cats and horses (not intended for food use) and is labeled: WARNING: Not for use in horses intended for food.
Human safety relative to possession, handling and administration:
Carcinogenesis: Nitrofurazone has been shown to produce mammary tumors in rats and ovarian tumors in mice. Some people may be hypersensitive to this product.
Either wear gloves when applying or wash hands afterwards.
KEEP OUT OF REACH OF CHILDREN
VI. AGENCY CONCLUSIONS:
The data submitted in support of this NADA comply with the conclusions of NAS/NRC review as concurred in by FDA and with CVM's policy concerning bioequivalence of topical drugs and demonstrate that Nitrofurazone Soluble Dressing (0.2% nitrofurazone ointment), when used under its approved conditions of use is safe and effective for the prevention or treatment of bacterial infections of wounds, burns and cutaneous ulcers on dogs, cats and horses (not for food use).
The drug is labeled for over the counter use for the following reasons:
- It is a generic topical antibacterial preparation with a long OTC marketing history of safe and effective use for the above indications.
- A diagnosis by a veterinarian is not necessary, as the labeled use conditions are easily recognized by the layman.
In view of the above, it is approved for over the counter marketing because adequate directions for use by the layman can be written.
- Nitrofurazone soluble dressing product label 4 and 16 oz.
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855