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Rx Item-XEPI ozenoxacin cream 30GM BY Biofrontera

RX70621-103-10 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-XEPI ozenoxacin cream 30GM BY Biofrontera

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XEPI ozenoxacin cream 30GM BY Biofrontera NDC No. 70621-0103-10 70621-103-10 70621010310 7062110310 UPC/GTIN No. 3-70621-10310-8 370621-103108 370621103108 MPN No.010310 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Impetigo

Xepi (ozenoxacin) is a topical non-fluorinated quinolone for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes. 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)

Store at 20C - 25C (68F - 77F); excursions permitted to 15C to 30C (59F - 86F) [See USP Controlled Room Temperature].
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 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: 12/2019
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Table of Contents
Table of Contents
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 ...
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 ...
3 DOSAGE FORMS AND STRENGTHS
Cream: 1%, pale yellow cream. Each gram of XEPI contains 10 mg of ozenoxacin.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
Potential for Microbial Overgrowth - The prolonged use of XEPI may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur during therapy, discontinue use and ...
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary - There are no available data on the use of XEPI in pregnant women to inform a drug associated risk. Systemic absorption of XEPI in humans is negligible following ...
10 OVERDOSAGE
Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.
11 DESCRIPTION
XEPI contains ozenoxacin, a quinolone antimicrobial. It is intended for topical use only. The chemical name of ozenoxacin is ...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - XEPI is an antimicrobial drug [see Microbiology (12.4)]. 12.2 Pharmacodynamics - Exposure-Response Relationship - The exposure response relationship for ozenoxacin ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential have not been conducted with ozenoxacin. Ozenoxacin demonstrated no ...
14 CLINICAL STUDIES
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 ...
16 HOW SUPPLIED/STORAGE AND HANDLING

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)

Store at 20C - 25C (68F - 77F); excursions permitted to 15C to 30C (59F - 86F) [See USP Controlled Room Temperature].
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RX70621-103-10
Rx Item-XEPI ozenoxacin cream 30GM BY Bi
RX70621-103-10

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-XEPI ozenoxacin cream 30GM BY Bi
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop