Dexamethasone, neomycin and thiabendazole

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Tresaderm ® (thiabendazole, dexamethasone, neomycin sulfate solution), 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 Tresaderm ® (thiabendazole, dexamethasone, neomycin sulfate solution) by Boehringer Ingelheim Animal Health USA Inc, a dexamethasone, neomycin and thiabendazole 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: Tresaderm ® (thiabendazole, dexamethasone, neomycin sulfate solution). Manufacturer: Boehringer Ingelheim Animal Health USA Inc. FDA Structured Product Label set id dfd55764-a280-45a0-a430-405ee7d7df40. Label effective 2023-11-17. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

Dermatologic Solution TRESADERM is indicated as an aid in the treatment of certain bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs and cats. Both acute and chronic forms of these skin disorders respond to treatment with TRESADERM. Many forms of dermatosis are caused by bacteria (chiefly Staphylococcus aureus , Proteus vulgaris and Pseudomonas aeruginosa ). Moreover, these organisms often act as opportunistic or concurrent pathogens that may complicate already established mycotic skin disorders, or otoacariasis caused by Otodectes cynotis . The principal etiologic agents of dermatomycoses in dogs and cats are species of the genera Microsporum and Trichophyton . The efficacy of neomycin as an antibacterial agent, with activity against both gram-negative and gram-positive pathogens, is well documented. Detailed studies in various laboratories have verified the significant activity thiabendazole displays against the important dermatophytes. Dexamethasone, a synthetic adrenocorticoid steroid, inhibits the reaction of connective tissue to injury and suppresses the classic inflammatory manifestations of skin disease. The formulation for TRESADERM combines these several activities in a complementary form for control of the discomfort and direct treatment of dermatitis and otitis externa produced by the above-mentioned infectious agents.

Dosage and Administration

Prior to the administration of Dermatologic Solution TRESADERM, remove the ceruminous, purulent or foreign materials from the ear canal, as well as the crust which may be associated with dermatoses affecting other parts of the body. The design of the container nozzle safely allows partial insertion into the ear canal for ease of administration. The amount to apply and the frequency of treatment are dependent upon the severity and extent of the lesions. Five to 15 drops should be instilled in the ear twice daily. In treating dermatoses affecting other than the ear the surface of the lesions should be well moistened (2 to 4 drops per square inch) with Dermatologic Solution TRESADERM twice daily. The volume required will be dependent upon the size of the lesion. Application of TRESADERM should be limited to a period of not longer than one week.

Warnings

For topical use in dogs and cats. Avoid contact with eyes. Keep this and all drugs out of the reach of children. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at www.fda.gov/reportanimalae.

Precautions

On rare occasions dogs may be sensitive to neomycin. In these animals, application of the drug will result in erythema of the treated area, which may last 24 to 48 hours. Also, evidence of transient discomfort has been noted in some dogs when the drug was applied to fissured or denuded areas. The expression of pain may last 2 to 5 minutes. Application of Dermatologic Solution TRESADERM should be limited to periods not longer than one week. While systemic side effects are not likely with topically applied corticosteroids, such a possibility should be considered if use of the solution is extensive and prolonged. If signs of salt and water retention or potassium excretion are noticed (increased thirst, weakness, lethargy, oliguria, gastrointestinal disturbances or tachycardia), treatment should be discontinued and appropriate measures taken to correct the electrolyte and fluid imbalance. Store in a refrigerator 36 - 46°F (2 - 8°C).

Description

Dermatologic Solution TRESADERM ® (thiabendazole, dexamethasone, neomycin sulfate solution) contains the following active ingredients per mL: 40 mg thiabendazole, 1 mg dexamethasone, 3.2 mg neomycin (from neomycin sulfate). Inactive ingredients: glycerin, propylene glycol, purified water, hypophosphorous acid, calcium hypophosphite; about 8.5% ethyl alcohol and about 0.5% benzyl alcohol.

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 dexamethasone and neomycin and thiabendazole 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: 641 reports

Reactions most often coded in dogs, 641 reports
VeDDRA reaction termReports
Deafness80
Vomiting60
Pinnal erythema57
Lethargy (see also Central nervous system depression in 'Neurological')48
Emesis33
Lack of efficacy - NOS33
Pinnal irritation30
Other abnormal test result NOS25
Anorexia22
Diarrhoea22
Accidental exposure20
Polyuria20
Seizure NOS20
Application site erythema18
Pustules18

Outcome as recorded by the reporter: Outcome Unknown 177; Recovered/Normal 107; Ongoing 81; Died 20; Euthanized 9; Recovered with Sequela 4.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Cats: 780 reports

Reactions most often coded in cats, 780 reports
VeDDRA reaction termReports
Vomiting106
Lethargy (see also Central nervous system depression in 'Neurological')94
Anorexia88
Ataxia85
Lethargy (see also Central nervous system depression in Neurological)75
Elevated alanine aminotransferase (ALT)74
Not eating68
Lack of efficacy - NOS55
Weight loss55
Behavioural disorder NOS47
Death by euthanasia44
Decreased appetite42
Other abnormal test result NOS41
Elevated total bilirubin40
Hyperglycaemia39

Outcome as recorded by the reporter: Outcome Unknown 310; Ongoing 162; Recovered/Normal 101; Euthanized 42; Died 38; Recovered with Sequela 3.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

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