FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. In case of accidental skin contact, wash area thoroughly with water. Avoid contact to the eyes.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Indication:
OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
History
There is currently no drug history available for this drug.
Other Information
OSURNIA contains 10 mg florfenicol, 10 mg terbinafine and 1 mg betamethasone acetate per mL and the inactive ingredients propylene carbonate, glycerol formal, hypromellose, phospholipid, oleic acid and BHT in an off-white to slightly yellow translucent gel.
OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
Sources
Saniwash Antimicrobial Manufacturers
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Safetec Of America, Inc.
Saniwash Antimicrobial | Novartis Animal Health Us, Inc.
OSURNIA should be administered in the clinic. Clean and dry the external ear canal before administering the initial dose of the product. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness). If alternative otic therapies are required it is recommended to clean the ear(s) before application.
Open tube by twisting the soft tip. Insert the flexible tip into the affected external ear canal(s) and squeeze entire tube contents into the external ear canal(s). After application, gently massage the base of the ear to allow the gel to penetrate to the lower part of the ear canal.
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