Sertaconazole Topical
Sertaconazole is an antifungal cream used to treat athlete's foot (interdigital tinea pedis) in adults and children 12 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Sertaconazole Topical: Patient Information Guide
A plain-language walkthrough of Sertaconazole Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Sertaconazole topical is an antifungal medication. Based on the available product evidence, it is approved for the following use:
- Ertaczo cream, 2%: Topical treatment of interdigital tinea pedis (athlete's foot between the toes) in immunocompetent adults and pediatric patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.
⚙️How it works▾
Sertaconazole is an azole antifungal. It targets a fungal enzyme — cytochrome P-450-mediated 14 alpha-lanosterol demethylase — that the fungus needs to convert lanosterol into ergosterol. Ergosterol is an essential building block of the fungal cell membrane. Without it, the membrane becomes unstable, starts to leak vital cell contents, and the fungal cell is damaged and dies.
In clinical studies, sertaconazole nitrate has shown activity specifically against Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum — the fungi that most commonly cause interdigital tinea pedis.
💊How it's taken▾
Ertaczo cream, 2% is applied directly to the skin (topical use only) twice a day for 4 weeks. Apply enough to cover the affected skin between the toes and the healthy skin right around it. This cream is not taken by mouth and is not used in the eyes or vaginal area.
- Dry the area thoroughly before each application, especially after bathing.
- Wash hands after applying.
- Do not wrap or cover the treated area tightly.
- Finish the full 4-week course even if your symptoms improve — stopping early raises the chance the infection comes back.
🤒Side effects — in detail▾
Most people tolerate Ertaczo cream well. The side effects reported in clinical trials were generally mild and occurred at similar rates to the inactive cream used for comparison.
- Contact dermatitis (skin irritation or rash)
- Dry skin
- Burning sensation on the skin
- Tenderness at the application site
- Redness (erythema) — reported after the product was on the market
- Itching (pruritus) — reported after the product was on the market
- Small blisters (vesiculation) — reported after the product was on the market
- Skin peeling (desquamation) — reported after the product was on the market
- Darkening of the skin (hyperpigmentation) — reported after the product was on the market
If irritation worsens or a significant skin reaction develops, stop using the cream and contact your doctor right away.
⚠️Warnings & precautions▾
- Skin irritation: If irritation develops at the application site, discontinue use and seek medical advice. Do not push through a worsening skin reaction.
- Azole cross-sensitivity: If you have previously reacted to another azole antifungal (such as clotrimazole or miconazole), tell your doctor before using sertaconazole — a similar reaction may occur.
- Not for eyes, mouth, or vaginal use: This is a topical skin cream only. Avoid contact with these areas.
🔀What it interacts with▾
The FDA label for Ertaczo cream does not identify specific drug, food, or supplement interactions for topical sertaconazole.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Azole antifungal allergy: Tell your doctor if you have ever had a reaction to any azole antifungal — cross-sensitivity is possible.
- Pregnancy: There are no human pregnancy studies for Ertaczo cream. Animal studies at high oral doses showed some concerns late in pregnancy. Discuss the risks and benefits with your doctor.
- Breastfeeding: It is not known whether sertaconazole passes into breast milk. Talk to your doctor about whether to continue breastfeeding while using this cream.
- Children under 12: The safety and effectiveness of Ertaczo cream have not been established in patients younger than 12 years old.
- Adults 65 and older: Clinical trials did not include enough older adults to confirm whether they respond differently. Use with your doctor's guidance.
- Weakened immune system: Ertaczo cream is approved only for patients with a normally functioning immune system (immunocompetent patients). If your immune system is weakened, talk to your doctor before use.
🔬Pharmacokinetics — how your body processes it▾
In a clinical study using Ertaczo cream, 2%, the cream was applied twice daily to the affected skin of people with interdigital tinea pedis. After multiple doses, blood levels of sertaconazole were below the detectable limit — meaning the medication was not meaningfully absorbed into the bloodstream through diseased skin at the amounts studied. This suggests that when used as directed on the skin, very little of the drug enters the body systemically.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
📄 Written from Sertaconazole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Sertaconazole Topical
6 supplements and herbal products have documented interactions with Sertaconazole Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 4
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Sertaconazole Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this cream for? ▾
How long do I need to use it, and what if my feet already feel better? ▾
Is there anything special I need to do before applying it? ▾
What side effects should I watch for, and when should I call my doctor? ▾
I've reacted to other antifungal creams before. Is this one safe for me? ▾
Can I use this cream if I'm pregnant or breastfeeding? ▾
Is Sertaconazole Topical available over the counter? ▾
When was Sertaconazole Topical first available? ▾
Who makes Sertaconazole Topical? ▾
💬 Answers drafted from Sertaconazole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Sertaconazole Topical comes
Sertaconazole Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Ertaczo cream, 2% is used to treat interdigital tinea pedis (athlete's foot between the toes) in immunocompetent adults and pediatric patients 12 years and older.
- Ertaczo cream is active against Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
- Ertaczo cream, 2% is applied to the affected skin between the toes and the immediately surrounding area twice daily for 4 weeks.
- Ertaczo cream should be applied to thoroughly dried skin; if you've just bathed, dry the area completely before applying.
- Wash your hands after applying Ertaczo cream, and do not cover the treated area with tight bandages or wrappings.
- Continue using Ertaczo cream for the full 4 weeks your doctor recommends, even if symptoms improve sooner.
📊 Sertaconazole Topical across the U.S. market
How Sertaconazole Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Sertaconazole Topical is used
A general measure of how commonly Sertaconazole Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sertaconazole Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sertaconazole Topical prescribed? Of the 1,596 medications we measure, Sertaconazole Topical ranks #892 by Medicaid prescriptions — more than 44% of them.
Utilization by Sertaconazole Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sertaconazole 20 MG/ML Topical Cream
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 250511
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sertaconazole Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Sertaconazole Topical NDCs with Medicaid activity.
🔍 Compare Sertaconazole Topical products
A representative set of FDA-listed product records for Sertaconazole Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 20 mg/g | Topical | Bausch Health US, LLC | NDA | View NDC → |
| 20 mg/g | Topical | Coral Way Pharma, LLC | NDA | View NDC → |
| 20 mg/g | Topical | Lacer Pharma, LLC | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Sertaconazole Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sertaconazole Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sertaconazole Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Sertaconazole Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 36435 1 dose form · 1 strength
-
Dose form (SCDF) Topical Cream RxCUI 377931In current FDA listingsClinical drug / strength (SCD) 20 MG/MLRxCUI 250511
Look up RxCUI 36435 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Sertaconazole Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Sertaconazole Topical belongs to the Azole Antifungal class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Lacer Pharma, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.