Finafloxacin Otic Suspension

Dosage Forms And Strengths

5 mL of a 0.3% topical otic suspension in an eight (8) mL bottle.

XTORO (finafloxacin otic suspension) 0.3% is a sterile, preserved, aqueous, otic suspension supplied in an opaque plastic bottle with a controlled drop tip and a white cap:

5 mL fill in an 8 mL bottle (NDC 0065-XXXX-XX)

Storage And Handling

Store at 2-25°C (36-77°F). Do not freeze.

Manufactured By: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-757-9785. Revised: December 2014.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

A total of 618 patients were treated with XTORO in two Phase 3 clinical trials. The most frequently reported adverse reactions of those exposed to XTORO occurring at an incidence of 1% included ear pruritus and nausea.