This page reprints a manufacturer label. Everything below in quotation marks is copied from Animax ® Ointment (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment), published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Animax ® Ointment (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment) by Dechra Veterinary Products, a nystatin, neomycin, thiostrepton and triamcinolone acetonide product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: Animax ® Ointment (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment). Manufacturer: Dechra Veterinary Products. FDA Structured Product Label set id 4452d0e8-4270-4f27-be2f-16eadd5fe248. Label effective 2026-03-24. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
Animax Ointment is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal ( Candida albicans ) infections. It is also of value in eczematous dermatitis, contact dermatitis, and seborrheic dermatitis; and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Dosage and Administration
Frequency of administration is dependent on the severity of the condition. For mild inflammations, application may range from once daily to once a week; for severe conditions Animax Ointment may be applied as often as two to three times daily, if necessary. Frequency of treatment may be decreased as improvement occurs. Wear gloves during the administration of the ointment or wash hands immediately after application. Otitis Clean ear canal of impacted cerumen. Inspect canal and remove any foreign bodies such as grass awns, ticks, etc. Instill three to five drops of Animax Ointment. Preliminary use of a local anesthetic may be advisable. Infected Anal Glands, Cystic Areas, etc. Drain gland or cyst and then fill with Animax Ointment. Other Dermatologic Disorders Clean affected areas, removing any encrusted discharge or exudate. Apply Animax Ointment sparingly in a thin film.
Warnings
Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in the offspring. In dogs, other congenital anomalies have resulted: deformed forelegs, phocomelia, and anasarca. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Precautions
Animax Ointment is not intended for the treatment of deep abscesses or deep-seated infections such as inflammation of the lymphatic vessels. Parenteral antibiotic therapy is indicated in these infections. Animax Ointment has been extremely well tolerated. Cutaneous reactions attributable to its use have been extremely rare. The occurrence of systemic reactions is rarely a problem with topical administration. There is some evidence that corticosteroids can be absorbed after topical application and cause systemic effects. Therefore, an animal receiving Animax Ointment therapy should be observed closely for signs such as polydipsia, polyuria, and increased weight gain. Animax Ointment is not generally recommended for the treatment of deep or puncture wounds or serious burns. Sensitivity to neomycin may occur. If redness, irritation, or swelling persists or increases, discontinue use. Do not use if pus is present since the drug may allow the infection to spread. Avoid ingestion. Oral or parenteral use of corticosteroids (depending on dose, duration of use, and specific steroid) may result in inhibition of endogenous steroid production following drug withdrawal. SIDE EFFECTS: SAP and SGPT (ALT) enzyme elevations, polydipsia and polyuria, vomiting, and diarrhea (occasionally bloody) have been observed following parenteral or systemic use of synthetic corticosteroids in dogs. Cushing's syndrome has been reported in association with prolonged or repeated steroid therapy in dogs. Temporary hearing loss has been reported in conjunction with treatment of otitis with products containing corticosteroids. However, regression usually occurred following withdrawal of the drug. Hearing loss, with varying degrees of recovery, has been reported with the use of Animax Ointment. If hearing dysfunction is noted during the course of treatment with Animax Ointment, discontinue its use. To report suspected adverse drug events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.
Description
Animax Ointment combines nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide in a non-irritating polyethylene and mineral oil base. Each mL contains: nystatin 100,000 units neomycin sulfate equivalent to neomycin base 2.5 mg thiostrepton 2,500 units triamcinolone acetonide 1 mg The preparation is intended for local therapy in a variety of cutaneous disorders of dogs and cats; it is especially useful in disorders caused, complicated, or threatened by bacterial and/or candidal (monilial) infection. ACTIONS: By virtue of its four active ingredients, Animax Ointment provides four basic therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial. Triamcinolone acetonide is a potent synthetic corticosteroid providing rapid and prolonged symptomatic relief on topical administration. Inflammation, edema, and pruritus promptly subside, and lesions are permitted to heal. Nystatin is the first well-tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous infections caused by Candida albicans (Monilia). Nystatin is fungistatic in vitro against a variety of yeast and yeast-like fungi including many fungi pathogenic to animals. No appreciable activity is exhibited against bacteria. Thiostrepton has a high order of activity against gram-positive organisms, including many which are resistant to other antibiotics; neomycin exerts antimicrobial action against a wide range of gram-positive and gram-negative bacteria. Together they provide comprehensive therapy against those organisms responsible for most superficial bacterial infections.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming nystatin and neomycin and thiostrepton and triamcinolone acetonide as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 826 reports
| VeDDRA reaction term | Reports |
|---|---|
| Deafness | 292 |
| Loss of hearing | 78 |
| Vomiting | 70 |
| Temporary deafness | 56 |
| Lack of efficacy - NOS | 51 |
| PR-EAR(S), LESION(S) | 39 |
| Diarrhoea | 38 |
| Partial deafness | 34 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 27 |
| Ear discharge | 24 |
| Lethargy (see also Central nervous system depression in Neurological) | 22 |
| Behavioural disorder NOS | 19 |
| Other abnormal test result NOS | 19 |
| Decreased appetite | 18 |
| Elevated alanine aminotransferase (ALT) | 18 |
Outcome as recorded by the reporter: Outcome Unknown 204; Recovered/Normal 161; Ongoing 149; Recovered with Sequela 69; Died 18; Euthanized 12.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 155 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 24 |
| Application site alopecia | 20 |
| Application site scab | 14 |
| Not eating | 14 |
| Lethargy (see also Central nervous system depression in Neurological) | 11 |
| Anorexia | 10 |
| Application site erythema | 10 |
| Application site pruritus | 10 |
| Ataxia | 10 |
| Death by euthanasia | 10 |
| Skin lesion NOS | 10 |
| Deafness | 9 |
| Lack of efficacy - NOS | 9 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 9 |
| Weight loss | 9 |
Outcome as recorded by the reporter: Ongoing 39; Recovered/Normal 38; Outcome Unknown 30; Euthanized 11; Died 6; Recovered with Sequela 5.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Animax ® Ointment (nystatin-neomycin sulfate-thiostrepton-triamcinolone acetonide ointment)FDA · retrieved 2026-09-16
“Frequency of administration is dependent on the severity of the condition.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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