Tri-Otic: Anti-fungal, Antibacterial, Anti-inflammatory Ear Drops
For the pain and inflammation of superficial bacterial and fungal infections of the external auditory canal. Rx Only
In a non-aqueous propylene glycol vehicle with 3% propylene glycol diacetate and benzalkonium chloride. ACTION: Tri-Otic is effective both as an antibacterial and antifungal agent. The special base is a hydrophilic solution having an acid pH and a low surface tension, exerting a drying effect and allowing the medication to spread quickly to all continguous surfaces, softening and reducing accumulated cerumen. Chloroxylenol is a halogenated phenol, non-toxic, non-corrosive, non-staining with high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood tissue. Tri-Otic which contains hydrocortisone is indicated when otitis is complicated by inflammation or to control itching. Pramoxine Hydrochloride is a topical anesthetic with a low index of sensitization and toxicity. Benzalkonium chloride lowers surface tension permitting better penetration of meatal skin. It also is a cationic germicide of high bactericidal and bacteriostatic potency. INDICATIONS: For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the anti-microbial, complicated by infection. CONTRAINDICATIONS: Topical steroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation. The preparation is not to be used for ophthalmic use and should not be applied in the external auditory canal of patients with perforated eardrums. PRECAUTIONS: If a favorable response does not occur promptly, discontinue the use of this preparation until the infection is controlled by other appropriate measures. Although systemic side effects are not common with topical corticosteroids, their possible occurrence must be kept in mind, particularly when used for an extended period of time. If local irritation or sensitization occurs, discontinue this preparation and institute other therapy. USAGE IN PREGNANCY: The safety of topical steroid preparation during pregnancy has not been established; therefore, they should not be used on pregnant patients. ADVERSE REACTIONS: The following adverse reactions with topical corticosteroids have been observed: itching, burning, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions and hypopigmentation. DOSAGE AND ADMINISTRATION: Carefully remove all the cerumen and debris and insert a wick saturated with this product (may be used without a wick). Instruct the patient to keep the wick moistened for the next 24 hours by occasionally adding a few drops on the wick. Remove the wick after their first 24 hours and continue to instill 5 drops for Adults, 3 drops for Children, 3 or 4 times daily thereafter. To prevent infection of the other ear during treatment, this product may be used in the unaffected ear 3 times daily. HOW SUPPLIED: Plastic dropper vials of 10 ml. NDC 00813-0393-11 << Back to Prescription Products Mailing address: PO Box 27554
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