THIDEXAVET- thiabendazole, dexamethasone, neomycin sulfate solution 
Dechra Veterinary Products LLC

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ANADA 200-565, Approved by FDA

ThiDexaVetTM Solution (Thiabendazole, Dexamethasone, Neomycin Sulfate Solution)

Dermatologic Solution

CAUTION: 

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Dermatologic Solution ThiDexaVet 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, puri­fed water, hypophosphorous acid, calcium hypophosphite; about 8.5% ethyl alcohol and about 0.5% benzyl alcohol.

INDICATIONS:

Dermatologic Solution ThiDexaVet Solution 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 ThiDexaVet Solution. Many forms of dermatosis are caused by bacteria (chiefly Staphylococcus aureusProteus 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 ThiDexaVet Solution 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 ThiDexaVet Solution, 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 ThiDexaVet Solution twice daily. The volume required will be dependent upon the size of the lesion. Application of ThiDexaVet Solution 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 ThiDexaVet Solution 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.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

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 Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain an MSDS, or for assistance call (866) 933-2472.

HOW SUPPLIED:

Dermatologic Solution ThiDexaVet Solution is supplied in
7.5 mL (NDC 17033-207-76) and
15 mL (17033-207-56)
dropper bottles, each in 6 bottle boxes.

Distributed by:

Dechra Veterinary Products
7015 College Boulevard
Suite 525
Overland Park
KS 66211

PRINCIPAL DISPLAY PANEL - 7.5 mL Bottle Carton

ThiDexaVet™ Solution
(Thiabendazole, Dexamethasone,
Neomycin Sulfate Solution)

Dermatologic Solution

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

ANADA 200-565, Approved by FDA

Net contents: 6 bottles, each containing 7.5 mL

Dechra

PRINCIPAL DISPLAY PANEL - 7.5 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

ThiDexaVet™ Solution
(Thiabendazole, Dexamethasone,
Neomycin Sulfate Solution)

Dermatologic Solution

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

ANADA 200-565, Approved by FDA

Net contents: 6 bottles, each containing 15 mL

Dechra

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

THIDEXAVET 
thiabendazole, dexamethasone, neomycin sulfate solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:17033-207
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIABENDAZOLE (UNII: N1Q45E87DT) (THIABENDAZOLE - UNII:N1Q45E87DT) THIABENDAZOLE40 mg  in 1 mL
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE1 mg  in 1 mL
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.2 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:17033-207-766 in 1 CARTON
17.5 mL in 1 BOTTLE
2NDC:17033-207-566 in 1 CARTON
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20056512/01/201612/08/2020
Labeler - Dechra Veterinary Products LLC (362142734)

Revised: 12/2020
 
Dechra Veterinary Products LLC