HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use XEPI™ safely and effectively. See full prescribing information for XEPI™. 

XEPI™ (ozenoxacin) cream, for topical use 

Initial U.S. Approval: 2017 

INDICATIONS AND USAGE 

XEPI 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 XEPI 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 XEPI 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 XEPI (6.1). 

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks at 866-262-0222 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2017

FULL PRESCRIBING INFORMATION: CONTENTS* 

1 INDICATIONS AND USAGE 

2 DOSAGE AND ADMINISTRATION 

3 DOSAGE FORMS AND STRENGTHS 

4 CONTRAINDICATIONS 

5 WARNINGS AND PRECAUTIONS 

6 ADVERSE REACTIONS 

6.1 Clinical Trials Experience 

8 USE IN SPECIFIC POPULATIONS 

8.1 Pregnancy 

8.2 Lactation 

8.4 Pediatric Use 

8.5 Geriatric Use 

10 OVERDOSAGE 

11 DESCRIPTION 

12 CLINICAL PHARMACOLOGY 

12.1 Mechanism of Action 

12.2 Pharmacodynamics 

12.3 Pharmacokinetics 

12.4 Microbiology 

13 NONCLINICAL TOXICOLOGY 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

14 CLINICAL STUDIES 

16 HOW SUPPLIED/STORAGE AND HANDLING 

17 PATIENT COUNSELING INFORMATION 

* Sections or subsections omitted from the full prescribing information are not listed.  

1 INDICATIONS AND USAGE 

XEPI™ 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 [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION 

Apply a thin layer of XEPI topically to the affected area twice daily for five days. 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.

Wash hands after applying XEPI cream.

XEPI cream is for topical use only.