Ertaczo 20 mg/g
Sertaconazole Nitrate · CREAM · Coral Way Pharma, LLC
Ertaczo is a cream containing sertaconazole nitrate at 20 mg/g, taken topical. Manufactured by Coral Way Pharma, LLC.
Key Facts
- Brand Name
- Ertaczo
- Generic Name
- Sertaconazole Nitrate
- NDC Code (Product)
85437-004- Manufacturer
- Coral Way Pharma, LLC
- Strength
- 20 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA021385
- Marketing Start
- 11/07/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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 Lacer Pharma, LLC at 1-888-403-8874 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 …
Frequently Asked Questions
What is Ertaczo used for?
Ertaczo contains Sertaconazole Nitrate. It is a cream taken topical. Consult your doctor for specific uses.
Is Ertaczo a controlled substance?
Ertaczo is not classified as a controlled substance by the DEA.
What is the generic name for Ertaczo?
The generic name for Ertaczo is Sertaconazole Nitrate. There are no other listed brand versions of Sertaconazole Nitrate.
What is the NDC code for Ertaczo 20 mg/g?
The NDC (National Drug Code) for Ertaczo 20 mg/g is 85437-004, listed by Coral Way Pharma, LLC.
Other Ertaczo Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)