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)].

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.
• Not for oral, ophthalmic, intranasal, or intravaginal use.
• The treated area may be covered with a sterile bandage or gauze dressing.

Cream: 1%, pale yellow cream. Each gram of XEPI contains 10 mg of ozenoxacin.

None.

Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.

XEPI contains ozenoxacin, a quinolone antimicrobial. It is intended for topical use only.

The chemical name of ozenoxacin is 1-Cyclopropyl-8-methyl-7-(5-methyl-6-methylamino-pyridin-3-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid. Ozenoxacin, a white to pale-yellow crystalline solid, has a molecular formula of C21H21N3O3, and a molecular weight of 363.41. The chemical structure is:

Each gram of cream contains 10 mg of ozenoxacin (1% w/w) and the following inactive ingredients: benzoic acid, octyldodecanol, peglicol 5 oleate, pegoxol 7 stearate, propylene glycol, purified water, stearyl alcohol.

The safety and efficacy of XEPI for the treatment of impetigo was evaluated in two multi-center, randomized, double-blind placebo controlled clinical trials (Trial 1, (NCT01397461) and Trial 2, (NCT02090764)). Seven-hundred twenty-three (723) subjects two months of age and older with an affected body surface area of up to 100 cm2, and not exceeding 2% for subjects aged 2 months to 11 years were randomized to XEPI or placebo. Subjects applied XEPI or placebo twice daily for 5 days. Subjects with underlying skin disease (e.g., preexisting eczematous dermatitis), skin trauma, clinical evidence of secondary infection, or systemic signs and symptoms of infection (such as fever), were excluded from these studies.

Overall clinical success was defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms assessed at the end of therapy (Day 6-7), as follows: absence of exudates/pus, crusting, tissue warmth, and pain; and erythema/inflammation, tissue edema, and itching assessed as less than mild in Trial 1; and absence of blistering, exudates/pus, crusting, and itching/pain, and mild or improved erythema/inflammation in Trial 2. Table 2 below presents the results for clinical response at the end of therapy.

The most commonly identified bacteria were S. aureus and S. pyogenes. Table 3 below presents the results for clinical success at end of therapy in subjects with S.aureus or S.pyogenes at baseline.

XEPI cream, 1% is a pale yellow cream supplied in a 30-gram tube. Each gram of cream contains 10 mg of ozenoxacin.

NDC 70621-103-01 (30-gram tube)
NDC 70621-103-10 (Cardbox containing one 30-gram tube)

Advise patients (and/or their caregivers or guardians) using XEPI of the following information and instructions:

• Use XEPI as directed by the healthcare practitioner. As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
• XEPI is for external use only.Do not swallow XEPI or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
• The treated area may be covered by a sterile bandage or gauze dressing.
• Use the medication for the entire time recommended by the healthcare practitioner, even though symptoms may have improved.
• Notify the healthcare practitioner if there is no improvement in symptoms within 3 days after starting use of XEPI.

Distributed by:
Biofrontera Inc.,120 Presidential Way, Suite 330, Woburn, MA 01801, USA

Xepi™ is a trademark used by Biofrontera Inc. and affiliates under a license from Ferrer Internacional, S.A..

© 2019 Biofrontera Inc.. All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

XepiTM
(ozenoxacin) Cream, 1%

NDC 70621-103-10

For Topical Use Only
Not for Ophthalmic, Oral, Intranasal, or Intravaginal Use

30g
Rx Only

Biofrontera

Note to pharmacist:
Tamper-evident container enclosed

Manufactured for:
Biofrontera Inc.,
Woburn, MA 01801
Rev. 12/2019

Each gram of XepiTM (ozenoxacin) Cream, 1% contains 10 mg Ozenoxacin in a cream base consisting of Benzoic Acid, Octyldodecanol, Peglicol 5 Oleate, Pegoxol 7 Stearate, Propylene Glycol, Purified Water, Stearyl Alcohol.

Store at 20ºC - 25ºC (68ºF - 77ºF); excursions permitted to 15ºC to 30ºC (59ºF - 86ºF) [See USP Controlled Room Temperature]. Protect from heat. Do not freeze.

Usual Dose: A thin layer should be applied to affected area twice daily for 5 days.
Warning: Keep out of reach of children.
See package insert for full prescribing information.