Regulatory PathRegulatory requirements compared

Active substance

Sertaconazole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DERMOFIX 2% CREAM2 %Cream · Topical1 TubeSAR 17.00NCE · PrescriptionFERRER INTERNATIONALValid
Indications — CHI Daman Drug Formulary

SEBORRHEIC DERMATITIS; TINEA CORPORIS, TINEA CRURIS, AND TINEA PEDIS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ERTACZO2%cream · topicalLACER PHARMAPrescription10 Dec 2003

Safety signals and safety-related labeling changes

All safety entries for sertaconazole →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.