Nitrofurazone: what the FDA reviewed for dog products
3 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Nitrofurazone, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs, cats and horses (not for food use); Dogs, cats, and horses (not for food use).
Products
- NFZ® Wound Dressing (NADA/ANADA 140-851)
- Nitrofurazone Ointment (NADA/ANADA 138-657)
- Nitrofurazone Soluble Dressing (NADA/ANADA 140-881)
NFZ® Wound Dressing NADA 140-851, Original approval, July 07, 1989; sponsor Neogen Corp.; species: Dogs, cats and horses (not for food use); foi_id 1365; FDA PDF
Indication
Prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use)
Dose regimen
0.2% nitrofurazone water-soluble ointment (amount per application not stated), Topical, not stated in summary
Water soluble antibacterial ointment containing 0.2% nitrofurazone
Effectiveness
No study: NAS/NRC DESI review of Furacin Dressing Veterinary (NADA 6-475), 44 FR 4014; bioequivalence waived under 21 CFR 320.22 policy for NAS/NRC-reviewed topicals; result: NAS/NRC concluded and FDA concurred that the product is effective; data neither required nor submitted
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.
Extraction notes: Pre-1962 generic topical; summary has no dosage regimen (route Topical only) and no safety, effectiveness or PK studies. Human warning notes nitrofurazone carcinogenicity in rats/mice.
Nitrofurazone Soluble Dressing NADA 140-881, Original approval, May 11, 1990; sponsor Med-Pharmex, Inc.; species: Dogs, cats and horses (not for food use); foi_id 1367; FDA PDF
Indication
Prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use)
Dose regimen
0.2% nitrofurazone soluble ointment (amount per application not stated), Topical, not stated in summary
demonstrate that Nitrofurazone Soluble Dressing (0.2% nitrofurazone ointment), when used under its approved conditions of use is safe and effective
Effectiveness
No study: NAS/NRC DESI review of Furacin Dressing Veterinary (NADA 6-475), 44 FR 4014; bioequivalence waived under 21 CFR 320.22 policy for NAS/NRC-reviewed topicals; result: NAS/NRC concluded and FDA concurred that the product is effective; data neither required nor submitted
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.
Extraction notes: Pre-1962 generic topical; summary has no dosage regimen (dosage form 'Soluble ointment for topical application', route Topical) and no safety, effectiveness or PK studies. The 0.2% strength is quoted from the Agency Conclusions.
Nitrofurazone Ointment NADA 138-657, Original approval, May 19, 1987; sponsor Sparhawk Laboratories, Inc.; species: Dogs, cats, and horses (not for food use); foi_id 1890; FDA PDF
Indication
Prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use)
Dose regimen
applied directly on the lesion (with a spatula or on gauze); 0.2% w/w ointment per dosage form, Topical, dressing may be changed several times daily or left on the lesion for a longer period, Preparation should remain on the lesion for at least 24 hours; bandage optional
Topical ointment containing 0.2% w/w nitrofurazone in a water-soluble base. Dispensing Status E. OTC Dosage Regimen F. 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.
Effectiveness
No study: NAS/NRC DESI review of Furacin Dressing Veterinary (NADA 6-475), 44 FR 4014; in vivo bioavailability/bioequivalence waived under 21 CFR 320.22 policy for NAS/NRC-reviewed topicals; result: NAS/NRC concluded and FDA concurred that the product is effective; effectiveness data under 21 CFR 514.111 not required
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.
Extraction notes: Pre-1962 generic topical; no safety, effectiveness or PK studies ('such data were neither required nor submitted'). The dose_regimen quote spans General Information headings D-F as flattened in the PDF text ('Dispensing Status E. OTC Dosage Regimen F.' are heading fragments).
Reproduce: foi_structured_search(query="Nitrofurazone") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).