XEPI™ INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Xepi™ (ozenoxacin) Cream, 1% is a topical prescription medicine approved for the treatment of impetigo, a common skin infection caused by bacteria (Staphylococcus aureus or Streptococcus pyogenes), and is approved for adults and children two months of age and older. The safety and effectiveness of Xepi™ have not been established in patients younger than 2 months of age. Use Xepi™ for the entire time, as directed by your Health Care Provider.
IMPORTANT SAFETY INFORMATION
Do not use Xepi™ if the affected area of impetigo is bigger than the size of the child’s two (2) hands.
Xepi™ is for external use only. Do not swallow Xepi™ or use in the eyes, on the mouth or lips, inside the nose, or inside the female genital area. Wash your hands after application if hands are not the area for treatment.
WARNINGS AND PRECAUTIONS:
The prolonged use of Xepi™ may result in hard-to-treat bacteria. Notify your healthcare practitioner if there is no improvement in symptoms within 3 days after starting use of Xepi™.
MOST COMMON SIDE EFFECTS
Rosacea (a skin condition that may include redness, flushing and acne-like lesions) and seborrheic dermatitis (a skin condition that causes scaly patches and red skin) were reported in 1 adult patient treated with Xepi™.
Please see accompanying full Prescribing Information for Xepi™.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.