IMPORTANT SAFETY INFORMATION

Uses: Xepi® is a topical prescription medicine approved for the treatment of impetigo, a skin infection caused by the bacteria Staphylococcus aureus or Streptococcus pyogenes, and is approved for adults and children two months of age and older.

Warnings:

When using this product:

  • Potential for Microbial Overgrowth: The prolonged use of Xepi® may result in hard-to-treat bacteria and fungi. Notify your healthcare practitioner if there is no improvement in symptoms within 3 days after starting use of Xepi®.

Most common side effects were:

  • 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®.

Pregnancy Warning: There is no available data on Xepi® use in pregnant women to inform a drug associated risk.

Lactation Warning: There is no available data regarding the presence of the active ingredient (ozenoxacin) in human milk, or the effects of ozenoxacin on the breastfed infant or on milk production.

Pediatric Warning: The safety and effectiveness of Xepi® in the treatment of impetigo have been established in patients 2 months to 17 years of age. The safety profile of Xepi® in patients 2 months and older was similar to that of adults.

The safety and effectiveness of Xepi® have not been established in patients younger than 2 months of age.

Geriatric Warning: Clinical studies of Xepi® did not include sufficient numbers of patients aged 65 and older to find out whether they respond differently from younger patients.

Directions:

  • Use Xepi® for the entire time, as directed by your Health Care Provider.
  • 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.

Inactive Ingredients: benzoic acid, octyldodecanol, peglicol 5 oleate, pegoxol 7 stearate, propylene glycol, purified water, stearyl alcohol

Other Information:

  • The risk information provided here is not comprehensive. To learn more, talk about Xepi® with your health care provider. The FDA approved product labeling can be found at https://www.xepicream.com/PI. You are encouraged to report side effects of Xepi®. Please contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.