XEPI™ INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Xepi™ (ozenoxacin) Cream, 1% is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older. Affected area may be up to 100 cm2 in adult and pediatric patients 12 years of age and older or 2% of the total body surface area and not exceeding 100 cm2 in pediatric patients less than 12 years of age.
The safety and effectiveness of Xepi™ in pediatric patients younger than 2 months of age have not been established.
Xepi™ is for external use only. Not for oral, ophthalmic, intranasal, or intravaginal use.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Prolonged use of Xepi™ may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy.
Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with Xepi™. The safety profile of Xepi™ in pediatric patients 2 months and older was similar to that of adults.
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.