Ertaczo

1 INDICATIONS AND USAGE ERTACZO ® cream, 2%, is 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 . 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 )

2 DOSAGE AND ADMINISTRATION Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved. Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Avoid the use of occlusive dressings or wrappings. For topical use. Not for ophthalmic, oral, or intravaginal use. 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 )

5 WARNINGS AND PRECAUTIONS 5.1 Local Adverse Reactions If irritation develops, discontinue treatment and institute appropriate therapy. Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to be sensitive to azole antifungals since cross-reactivity may occur.

4 CONTRAINDICATIONS None. None. ( 4 )

8.1 Pregnancy Risk Summary There are no available data on ERTACZO cream, 2% use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses 40 and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison. In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses 20 and 40 times the MRHD based on BSA comparison ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal embryofetal development studies have not been conducted with ERTACZO cream, 2%. Embryofetal development studies performed in pregnant rats and rabbits administered oral doses of sertaconzaole nitrate up to 160 mg/kg/day (40 times [rats] and 80 times [rabbits] the MRHD based on a BSA comparison) during the period of organogenesis revealed no malformations or embryofetal developmental toxicity. In a pre- and postnatal development study, pregnant rats were administered oral doses of sertaconazole nitrate from pregnancy day 6 to lactation day 20. A reduction in live birth indices and an increase in the number of still-born pups were seen at doses 20 and 40 times the MRHD based on BSA comparison.

6 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 Coral Way Pharma, LLC at 1-888-402-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness. In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.