Derma 4 Ointment — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Derma 4 Ointment

Active ingredient

Neomycin Sulfate Nystatin Thiostrepton Triamcinolone Acetonide

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 17, 2017

Adverse event reports

Source: openFDA VeDDRA

888

Reports mentioning this ingredient

February 7, 1995 – March 18, 2026

216

Classified serious

per reporter assessment

80

Lack of expected efficacy

resistance signal

23

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “NEOMYCIN SULFATE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Vomiting	67
Lethargy (see also Central nervous system depression in 'Neurological')	66
Lethargy (see also Central nervous system depression in Neurological)	61
Vials, Damaged	59
Elevated alanine aminotransferase (ALT)	49
Not eating	49
Lack of efficacy - NOS	47
Anorexia	36
Underdose	36
Containers, Leaking	34
Ataxia	32
Closure, Abnormal	31
Weight loss	29
Seal, Abnormal	28
Eye irritation	28
Drug administration duration too long	28
Other abnormal test result NOS	28
Elevated total bilirubin	28
Death by euthanasia	26
Containers, Abnormal	26

Species affected

Source: openFDA VeDDRA

Cat 416 Dog 214 Human 60 Cattle 7 Ferret 3 Goat 1 Pig 1 Mouse 1 Guinea Pig 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient