Ertaczo
Generic: SERTACONAZOLE NITRATE
Basic Information
Manufacturer
Coral Way Pharma, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
c6fa8dc4-2620-474e-a9b4-6657d9cbfa96
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 )
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 )
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 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.
( 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.