FDA-filed SPL labeling · retrieved through openFDA

Naftifine Topical

Naftifine is a topical antifungal used to treat common fungal skin infections, including athlete's foot (tinea pedis) and ringworm (tinea corporis).

Brand name Naftin
Drug class ⓘ Allylamine Antifungal
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 6 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 →

At a glance
Linked label effectiveNov 8, 2025
Clinical labels in scope ⓘ6
AvailabilityRx
Earliest approval/marketing year ⓘ1988
FDA-listed product records ⓘ15
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Naftifine Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Naftifine topical is an effective antifungal for treating athlete's foot, ringworm, and jock itch caused by common dermatophyte fungi. Apply it once daily to the affected skin area as directed, and don't stop early even if it starts to look better. If irritation worsens or you have concerns, reach out to your pharmacist or prescriber.

📖 Naftifine Topical: Patient Information Guide

A plain-language walkthrough of Naftifine 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▾

Naftifine is a topical antifungal used to treat dermatophyte (fungal) skin infections. Supported uses across the available products include:

  • Naftin gel 2%: interdigital tinea pedis (athlete's foot between the toes) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum — approved for use in patients aged 12 and older
  • Naftifine hydrochloride cream: tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) in adults and children as young as 2 years of age
⚙️How it works▾

Naftifine belongs to a class of antifungals called allylamines. It works by blocking an enzyme — squalene 2,3-epoxidase — that fungi rely on to produce ergosterol, the key building block of their cell membranes. Without enough ergosterol, fungal cells are weakened and can't grow or spread. At the same time, a substance called squalene builds up inside the fungal cells, which adds to their damage.

No mechanism of resistance to naftifine has been identified to date. The drug penetrates the outer layer of the skin (stratum corneum) deeply enough to reach the fungi living there.

💊How it's taken▾

Naftifine is applied to the skin once daily. Apply a thin layer to the affected area and about a half-inch of the healthy skin around it. Treatment is typically continued for 2 weeks — complete the full course even if symptoms improve early.

  • For topical (skin) use only — not for use in the eyes, mouth, or vaginally
  • Wash your hands before and after applying
  • Follow your prescriber's specific directions for your product and condition
🤒Side effects — in detail▾

Most side effects from naftifine are mild and happen at the site where you apply it. Common reactions include:

  • Itching (pruritus) — the most frequently reported reaction
  • Redness or irritation
  • Burning
  • Swelling
  • Blisters
  • Crusting or watery (serous) drainage
  • Maceration (skin softening from moisture)

Rarely, reactions reported after the product was on the market include headache, dizziness, and uncommon blood cell changes (low white blood cell counts). Stop using naftifine and call your doctor if irritation gets worse or if you experience any unexpected systemic symptoms.

⚠️Warnings & precautions▾
  • Skin irritation: If redness, burning, or sensitivity develops or worsens where you're applying naftifine, stop using it and contact your doctor.
  • For skin use only: Do not let this product get into your eyes, mouth, or vaginal area.
  • Allergic reactions: People who are allergic to any ingredient in naftifine products should not use them.
  • Post-market reports: Rare cases of blood cell changes (leukopenia, agranulocytosis — abnormally low white blood cell counts) have been reported; seek medical attention if you notice unusual bruising or signs of infection.
🔀What it interacts with▾

The FDA label for naftifine topical does not identify specific drug, food, or substance interactions.

    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▾
    • Allergy: Do not use naftifine cream if you are allergic to naftifine or any of its components.
    • Pregnancy: There are no human data on naftifine use during pregnancy — talk to your doctor before using.
    • Breastfeeding: It is unknown whether naftifine passes into breast milk; discuss the benefits and risks with your doctor before using while nursing.
    • Children: Naftin gel 2% has established safety and effectiveness only for patients aged 12 and older with tinea pedis. Naftifine cream has safety and pharmacokinetic data in children as young as 2 years old for tinea corporis, tinea pedis, and tinea cruris.
    • Eyes, mouth, and genitals: Keep naftifine away from these areas entirely.
    🔬Pharmacokinetics — how your body processes it▾

    After you apply naftifine to your skin, it penetrates the outermost skin layer (the stratum corneum) deeply enough to inhibit fungal growth in the tissue. A small amount is absorbed into the bloodstream — this increases slightly over a two-week treatment course but remains at very low levels. The tiny fraction that is absorbed is mostly eliminated through urine, with less than 0.004% of the applied dose excreted that way.

    Studies in adults and children (ages 2 to 18) all confirmed measurable but very low blood levels after once-daily application, with accumulation after 14 days remaining less than twofold. In some adults, naftifine could still be detected in the blood two weeks after stopping treatment, though at very low concentrations.

    📦How to store it▾

    Store NAFTIN ® Gel at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) .

    📄 Written from Naftifine 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 →

    20

    Supplements & herbs that interact with Naftifine Topical

    20 supplements and herbal products have documented interactions with Naftifine Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

    Severity mix
    • Major · 1
    • Moderate · 7
    • Minor · 12
    Every supplement checked against Naftifine Topical — ranked by severity The full interaction hub: 1 major · 7 moderate · 12 minor · every one linked to its full report. Check Naftifine Topical against your exact supplements

    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 Naftifine Topical — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly is naftifine used to treat? ▾
    Naftifine is an antifungal medicine applied to the skin to treat common fungal infections. The gel form (2%) is specifically approved for athlete's foot between the toes — that itchy, scaly infection you get in the web spaces. The cream form has been used for athlete's foot, jock itch, and ringworm. Your prescriber will recommend the right product for your specific infection.
    How do I apply it, and how long do I need to use it? ▾
    Apply a thin layer once a day to the infected area plus a small border — about a half-inch — of the healthy skin around it. Treatment generally lasts 2 weeks. It's important to finish the full course even if your skin starts looking better early, because stopping too soon can allow the infection to come back. Follow the directions on your specific product label.
    What side effects should I expect, and when should I call my doctor? ▾
    Most people tolerate naftifine well. The most common reaction is itching at the application site. You might also notice some redness, mild burning, or temporary irritation. These are usually mild and settle down. However, if irritation gets significantly worse — especially new or worsening redness, swelling, or blistering — stop applying it and call your doctor. Rare reactions including dizziness and headache have also been reported.
    Can I use this if I'm pregnant or breastfeeding? ▾
    There's no human safety data on naftifine during pregnancy, so it's important to have a conversation with your doctor before using it. For breastfeeding, it's unknown whether any of the medication passes into breast milk. Your doctor can help you weigh the benefits of treating the infection against any potential risk to your baby.
    Is naftifine safe for children? ▾
    It depends on the specific product and your child's age. The 2% gel has established safety and effectiveness for teenagers 12 and older with athlete's foot between the toes. The cream formulation has been studied in children as young as 2 years old for ringworm, athlete's foot, and jock itch. Always check with your child's doctor to make sure you have the right product for your child's age and condition.
    Are there any important things to avoid while using naftifine? ▾
    Keep the product away from your eyes, mouth, and vaginal area — it's strictly for use on the skin. If it accidentally gets into your eyes, rinse well with water. Stop using it and contact your doctor if you develop an allergic reaction — signs could include severe skin irritation or rash at the site. There are no specific food or drug interactions listed for naftifine, but always tell your doctor and pharmacist about all the medications you use.
    Is Naftifine Topical available over the counter? ▾
    Naftifine Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
    When was Naftifine Topical first available? ▾
    Naftifine Topical has been available in the United States since at least 1988, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Naftifine Topical? ▾
    Naftifine Topical is supplied by 6 manufacturers listed in the FDA NDC Directory, including Sebela Pharmaceuticals Inc., Taro Pharmaceuticals U.S.A., Inc., Sun Pharmaceutical Industries, Inc..

    💬 Answers drafted from Naftifine 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 Naftifine Topical comes

    Naftifine 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

    On the skin
    Brands Naftin
    How this form is used
    What it may be used for
    • Naftin gel 2% is used to treat interdigital tinea pedis (athlete's foot between the toes) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum
    • Naftin cream has been used to treat tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) in adults and children aged 2 and older
    Important instructions
    • Naftin gel 2%: apply a thin layer once daily to the affected area plus about a half-inch margin of surrounding healthy skin
    • Naftin gel 2%: for topical use on skin only — do not use in the eyes, mouth, or vaginally
    • Naftin cream: apply once daily to the affected skin area plus a half-inch margin of healthy surrounding skin
    • Follow your prescriber's guidance on how long to continue treatment
    Available strengths 3 strengths
    15 FDA-listed product records ⓘ

    📊 Naftifine Topical across the U.S. market

    How Naftifine 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.

    1
    Dose forms ⓘ
    6
    Manufacturers
    2
    Brand names
    15
    FDA-listed product records ⓘ
    1988
    First marketed ⓘ
    Sebela Pharmaceuticals Inc.27%
    Taro Pharmaceuticals U.S.A., Inc.27%
    Sun Pharmaceutical Industries, Inc.20%
    Amneal Pharmaceuticals of New York LLC13%
    Legacy Pharma USA Inc.7%
    Xiromed, LLC7%

    Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    📈 How widely Naftifine Topical is used

    A general measure of how commonly Naftifine 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 Naftifine 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.

    1,859
    Medicaid prescriptions filled (Q1–Q4 2025)
    $637,635 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Naftifine Topical prescribed? Of the 1,597 medications we measure, Naftifine Topical ranks #1,198 by Medicaid prescriptions — more than 25% of them.

    Where Naftifine Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

    Utilization by Naftifine 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.

    The 20 mg/mL topical cream is the most-dispensed Naftifine Topical product — about 41% of these Medicaid prescriptions.

    naftifine hydrochloride 20 MG/ML Topical Cream Most dispensed

    766 Medicaid prescriptions (Q1–Q4 2025) 41% of Naftifine Topical prescriptions shown $105,117 gross reimbursement (before rebates) ≈ $137 per prescription (gross)

    Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1246096

    naftifine hydrochloride 0.02 MG/MG Topical Gel

    637 Medicaid prescriptions (Q1–Q4 2025) 34% of Naftifine Topical prescriptions shown $322,708 gross reimbursement (before rebates) ≈ $507 per prescription (gross)

    Summed across the 4 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1433734

    naftifine hydrochloride 10 MG/ML Topical Cream

    456 Medicaid prescriptions (Q1–Q4 2025) 25% of Naftifine Topical prescriptions shown $209,810 gross reimbursement (before rebates) ≈ $460 per prescription (gross)

    Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896110

    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 Naftifine 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 8 of 19 listed Naftifine Topical NDCs with Medicaid activity.

    🔍 Compare Naftifine Topical products

    A representative set of FDA-listed product records for Naftifine 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
    10 mg/g Topical Amneal Pharmaceuticals of New York LLC ANDA View NDC →
    20 mg/g Topical Amneal Pharmaceuticals of New York LLC ANDA View NDC →
    2 g/100 g Topical Legacy Pharma USA Inc. NDA View NDC →
    10 mg/g Topical Sebela Pharmaceuticals Inc. NDA View NDC →
    2 g/100 g Topical Sebela Pharmaceuticals Inc. × 3 listings NDA View NDC →
    10 mg/g Topical Sun Pharmaceutical Industries, Inc. ANDA View NDC →
    20 mg/g Topical Sun Pharmaceutical Industries, Inc. × 2 listings ANDA View NDC →
    10 mg/g Topical Taro Pharmaceuticals U.S.A., Inc. ANDA View NDC →
    20 mg/g Topical Taro Pharmaceuticals U.S.A., Inc. × 3 listings ANDA View NDC →
    20 mg/g Topical Xiromed, LLC ANDA View NDC →

    Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Naftifine Topical NDCs →

    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.

    Ingredient (IN) Naftifine Topical RxCUI 31476 2 dose forms · 4 strengths
    1. Dose form (SCDF) Topical Gel RxCUI 487271 In current FDA listings
      Clinical drug / strength (SCD) hydrochloride 0.01 MG/MG RxCUI 896106 hydrochloride 0.02 MG/MG RxCUI 1433734

    Look up RxCUI 31476 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.

    🏷️ Sold under these brand names

    Naftin

    🏭 Manufacturers & labelers

    Sebela Pharmaceuticals Inc. 4 Taro Pharmaceuticals U.S.A., Inc. 4 Sun Pharmaceutical Industries, Inc. 3 Amneal Pharmaceuticals of New York LLC 2 Legacy Pharma USA Inc. 1 Xiromed, LLC 1

    RxNorm drug class

    Naftifine Topical belongs to the Allylamine Antifungal class.

    Pharmacologic class Allylamine Antifungal
    Drug family (ATC) Other antifungals for topical use

    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.

    📄
    FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 8, 2025
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Naftifine Topical.
    📈
    Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
    🚨
    Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
    🧾 Clinical label set — FDA-filed SPL labels retained for Naftifine Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    6
    NDC products indexed
    15
    Distinct labelers/manufacturers represented
    6
    Linked representative label ⓘ
    Sebela Pharmaceuticals Inc.
    Linked label effective
    Nov 8, 2025
    Composite sections available
    22
    Linked SPL Set ID
    6645994a-ecb3-277b-e053-2a91aa0a81e5
    Linked SPL Document ID
    43150f38-df38-5e12-e063-6294a90a1128
    Open the linked representative label on DailyMed ↗

    How we combine label and product data

    HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 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. Sebela Pharmaceuticals Inc. 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.