HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ERTACZO Cream safely and effectively. See full prescribing information for ERTACZO Cream. For full prescribing information click here

ERTACZO® (sertaconazole nitrate) cream, for topical use

INDICATIONS AND USAGE

ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. (1)

DOSAGE AND ADMINISTRATION

• Apply ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks.(2)

• Not for ophthalmic, oral, or intravaginal use.(2)

DOSAGE FORMS AND STRENGTHS

Cream, 2%. (3)

CONTRAINDICATIONS

None. (4)

ADVERSE REACTIONS

Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.