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Topical Antibiotic-Steroid
NADA No.: 140-810

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Active Ingredients:

Each mL contains:
Nystatin – 100,000 units
Neomycin sulfate (equivalent to neomycin base) – 2.5 mg
Thiostrepton – 2,500 units
Triamcinolone acetonide – 1.0 mg
In a polyethylene and mineral oil gel base.

Indications:

DERMALONE Ointment is 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:

The frequency of administration is dependent upon the severity of the condition. For mild inflammations, application may range from once a day to once a week; for severe conditions DERMALONE Ointment may be applied as often as two (2) to three (3) times a day. The 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 the ear canal of impacted cerumen. Inspect the ear canal and remove any foreign bodies such as grass awns, ticks, etc. Instill three (3) to five (5) drops of DERMALONE Ointment. Preliminary use of a local anesthetic such as proparacaine hydrochloride ophthalmic solution may be advisable. Infected anal glands, cystic areas, etc.: Drain the gland or cyst and then fill with DERMALONE Ointment. Other dermatologic disorders: Clean the affected areas, removing any encrusted discharge of exudate. Apply DERMALONE Ointment (nystatin-neomycin sulfate- thiostrepton-triamcinolone acetonide ointment) sparingly in a thin film.

Precautions:

Store at room temperature; avoid excessive heat (104°F).

Cautions:

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

DERMALONE 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. DERMALONE Ointment has been well tolerated. Cutaneous reactions attributable to its use have been 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 DERMALONE Ointment therapy should be observed closely for signs such as polydipsia, polyuria, and increased body weight gain. DERMALONE 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 the inhibition of endogenous steroid production following drug withdrawal. Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain that the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue the use of DERMALONE Ointment.

Warnings:

For use in dogs and cats only.

KEEP OUT OF REACH OF CHILDREN

Presentation:

7.5 mL, 15 mL and 30 mL tubes with elongated tip applicator, packaged 12 each per carton. 8 oz bottles packaged in individual cartons. Also available in a nested carton containing 144/7.5 mL tubes.

VEDCO - 11/10/98.1