Indication and Important Safety Information

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XEPITM safely and effectively. See full prescribing information for XEPITM.
XEPITM (ozenoxacin) cream, for topical use 
Initial U.S. Approval:  2017
-----------------------------INDICATIONS AND USAGE--------------------------
XEPITM is a quinolone antimicrobial 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 (1).
------------------------DOSAGE AND ADMINISTRATION----------------------
Apply a thin layer of XEPITM topically to the affected area twice daily for 5 days (2). 
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 (2).
For topical use only (2).
Not for oral, ophthalmic, intranasal, or intravaginal use (2). 

---------------------DOSAGE FORMS AND STRENGTHS---------------------
Cream: Each gram contains 10 mg of ozenoxacin (1%) (3).

-------------------------------CONTRAINDICATIONS------------------------------
None (4)
 
------------------------WARNINGS AND PRECAUTIONS-----------------------
Potential for Microbial Overgrowth: Prolonged use of XEPITM may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy (5).
 
-------------------------------ADVERSE REACTIONS------------------------------
Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPITM (6.1). 

To report SUSPECTED ADVERSE REACTIONS, contact Cutanea Life Sciences, Inc. at 1-844-780-8152 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
                            
Revised: 01/2018