INDICATIONS & 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.
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.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
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.
ADVERSE REACTIONS
Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness.
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.
Full Prescribing Information: DailyMed
