Label: TRESADERM- thiabendazole, dexamethasone, neomycin sulfate solution

  • NDC Code(s): 0010-5587-01, 0010-5587-02, 0010-5587-03, 0010-5587-04
  • Packager: Boehringer Ingelheim Animal Health USA Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated December 17, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Dermatologic Solution

    Approved by FDA under NADA # 042-633

  • CAUTION

    Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

  • 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.

  • 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.

  • 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.

  • STORAGE AND HANDLING

    Store in a refrigerator 36 - 46°F (2 - 8°C).

  • WARNING

    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.

  • HOW SUPPLIED

    Products 128740 & 128741 - Dermatologic Solution TRESADERM Veterinary is supplied in 7.5 mL and 15 mL dropper bottles, each in 12 bottle boxes.

  • SPL UNCLASSIFIED SECTION

    Marketed by
    Boehringer Ingelheim Animal Health USA Inc.
    Duluth, Georgia 30096

    © 2019 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.

    October 2018

    ®TRESADERM is a registered trademark of Boehringer Ingelheim Animal Health USA Inc.

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Tresaderm®
    (thiabendazole, dexamethasone,neomycin sulfate solution)

    Dermatologic Solutionfor Dogs and Cats

    CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

    12 x 15 mL Bottles

    Principal Display Panel - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TRESADERM 
    thiabendazole, dexamethasone, neomycin sulfate solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0010-5587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    dexamethasone (UNII: 7S5I7G3JQL) (dexamethasone - UNII:7S5I7G3JQL) dexamethasone1 mg  in 1 mL
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin3.2 mg  in 1 mL
    thiabendazole (UNII: N1Q45E87DT) (thiabendazole - UNII:N1Q45E87DT) thiabendazole40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    hypophosphorous acid (UNII: 8B1RL9B4ZJ)  
    calcium hypophosphite (UNII: CUI83R2732)  
    alcohol (UNII: 3K9958V90M)  
    benzyl alcohol (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0010-5587-0212 in 1 CARTON
    1NDC:0010-5587-017.5 mL in 1 BOTTLE, WITH APPLICATOR
    2NDC:0010-5587-0412 in 1 CARTON
    2NDC:0010-5587-0315 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA04263311/03/2020
    Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)