FDA-filed SPL labeling · retrieved through openFDA

Oxiconazole

Oxiconazole is an antifungal ingredient used in topical creams and lotions to treat common fungal skin infections including ringworm, jock itch, athlete's foot, and tinea versicolor.

Brand names OxistatOxiconazole Nitrate
Drug classes Azole 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 3 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 effectiveJan 28, 2026
Clinical labels in scope 3
AvailabilityRx
Earliest approval/marketing year 1984
FDA-listed product records 11
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Oxiconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oxiconazole is a reliable topical antifungal for treating athlete's foot, jock itch, ringworm, and — with the cream form — tinea versicolor. Apply it as directed and finish the full treatment course to prevent the infection from returning. Side effects are generally mild and local, but stop using it and call your doctor if you notice signs of a serious skin reaction.

📖 Oxiconazole: Patient Information Guide

A plain-language walkthrough of Oxiconazole — 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

Oxiconazole is a topical antifungal used to treat several common fungal skin infections. Specific approved uses depend on the product and formulation.

  • Oxiconazole Nitrate cream is approved for tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm)
  • Oxiconazole Nitrate cream is approved for tinea (pityriasis) versicolor — a fungal infection that causes lighter or darker patches, often on the trunk, neck, arms, or upper thighs
  • Oxiconazole Nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor, though these conditions are uncommon in children under 12
  • Oxistat Lotion is approved for tinea pedis, tinea cruris, and tinea corporis — but is not indicated for tinea (pityriasis) versicolor
⚙️How it works

Oxiconazole is an imidazole antifungal. It works by blocking a key step in the production of ergosterol — a substance fungi depend on to keep their cell membranes intact and functioning. When ergosterol production is disrupted, the fungal cell membrane weakens and the organism can no longer survive. This targeted action makes oxiconazole effective against the specific fungi that cause athlete's foot, ringworm, jock itch, and tinea versicolor.

The drug penetrates into the outer layers of the skin where these infections live, and very little — less than 0.3% of the applied dose — is absorbed into the bloodstream. This means it works locally, right where the problem is.

💊How it's taken

Oxiconazole is applied directly to the affected skin and the area around it. The frequency and length of treatment depend on the infection.

  • Oxiconazole Nitrate cream for tinea pedis, tinea corporis, or tinea cruris: apply once or twice daily; treat tinea corporis and tinea cruris for 2 weeks, and tinea pedis for 1 month
  • Oxiconazole Nitrate cream for tinea (pityriasis) versicolor: apply once daily for 2 weeks
  • Oxistat Lotion for tinea pedis, tinea corporis, or tinea cruris: apply once or twice daily; treat tinea corporis and tinea cruris for 2 weeks, and tinea pedis for 1 month

Always follow your prescriber's instructions. If your skin doesn't improve after completing treatment, follow up with your doctor.

🤒Side effects — in detail

Most side effects from oxiconazole are mild and happen right where you apply it. Common reactions reported in clinical trials include:

  • Itching (pruritus)
  • Burning or stinging
  • Skin irritation
  • Allergic contact dermatitis (rash caused by skin sensitivity)
  • Folliculitis (irritated hair follicles)
  • Redness (erythema)
  • Scaling, fissures (skin cracks), or maceration (skin softening from moisture)
  • Small bumps (papules) or nodules

If you notice signs of a more serious skin reaction — such as significant swelling, severe rash, or worsening irritation — stop using the product and contact your doctor.

⚠️Warnings & precautions
  • For skin use only. Oxistat Lotion and oxiconazole products must not be swallowed, applied to the eyes, or used inside the vagina. If accidental contact occurs, rinse well and seek medical advice.
  • Do not use if you have a known allergy to oxiconazole or any other ingredient in the product. If an allergic skin reaction develops during treatment, discontinue use and consult your prescriber.
  • Completing the full treatment course is important to reduce the risk of the infection coming back, even if your skin looks better before the course is done.
  • With tinea (pityriasis) versicolor, skin color may not return to normal right away after the infection clears — pigment normalization can take months and may depend on sun exposure and individual skin type.
🔀What it interacts with

Potential drug interactions between oxiconazole and other medications have not been formally studied. If you use other topical skin products on the same area, let your prescriber or pharmacist know.

  • No specific drug interactions have been identified in the FDA label — but always tell your healthcare provider about all products you are applying to your skin

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
  • Do not use oxiconazole if you have had an allergic reaction to it or to any ingredient in the formulation
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding before using this medication
  • Oxiconazole Nitrate cream may be used in children for certain fungal skin infections, but these conditions are uncommon in kids under 12 — always check with your child's doctor first
  • Keep the product away from eyes, mouth, and the vaginal area
🚑If you take too much

No overdose cases in humans have been reported with oxiconazole cream or lotion. In animal studies, applying a much stronger concentration over a large area of skin for an extended period caused skin inflammation and other serious effects — but this does not reflect normal use. If you accidentally ingest any of this product, contact Poison Control or seek medical attention right away.

📡Pharmacodynamics — effects in the body

Oxiconazole works by disrupting the production of ergosterol, a critical component of the fungal cell membrane. Without adequate ergosterol, the membrane loses its integrity and the fungus cannot survive. It has demonstrated activity against the organisms responsible for athlete's foot, jock itch, ringworm, and tinea versicolor, including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Malassezia furfur.

🔬Pharmacokinetics — how your body processes it

After oxiconazole nitrate cream is applied to the skin, the medication penetrates into the outer skin layers — the epidermis and corium (dermis) — where fungal infections take hold. Systemic absorption is very low: less than 0.3% of the applied dose was detected in the urine of study participants over 5 days. This means the drug works mainly at the site of application, with minimal entry into the rest of the body. No studies have been conducted to compare how the cream and lotion formulations penetrate the skin relative to each other.

📦How to store it

Store at 20° – 25°C (68° – 77°F) .

📄 Written from Oxiconazole’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 →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Oxiconazole — the kind of thing our pharmacy team would talk through with you at the counter.

What kinds of infections does oxiconazole actually treat?
It treats fungal skin infections — specifically athlete's foot (the itchy, scaly rash between your toes), jock itch (a rash in the groin area), ringworm (a ring-shaped rash on the body), and tinea versicolor (a condition that causes lighter or darker patches on the skin). The cream form covers all four; the Oxistat Lotion is approved for the first three but not tinea versicolor. These are caused by specific types of fungi, not bacteria, so it won't help with bacterial infections.
How long do I need to use it before it starts working?
You may start to see improvement before you finish the full course, but it's important to keep using it for the entire recommended period — 2 weeks for ringworm, jock itch, and tinea versicolor, and a full month for athlete's foot. Stopping early is one of the most common reasons these infections come back. If things don't look better after you finish the full course, that's the time to check back in with your doctor.
The patches from my tinea versicolor haven't faded even though the fungus seems gone — is that normal?
Yes, completely normal. The skin discoloration — lighter or darker patches — is caused by the infection, but clearing the fungus doesn't automatically restore your skin color right away. The pigment can take months to return to normal, and it depends on your skin type and how much sun exposure you get. The good news is that the infection itself is treated; the color change is just your skin catching up.
What side effects should I watch for?
Most people only notice mild reactions right where they apply it — things like itching, burning, or a little irritation. These are usually short-lived. What you'd want to call your doctor about is anything more serious: a significant rash spreading beyond the area you're treating, noticeable swelling, or skin that seems to be getting worse instead of better. That could signal an allergic reaction to the medication itself.
Can I use this on my child?
Oxiconazole Nitrate cream can be used in children for ringworm, jock itch, athlete's foot, and tinea versicolor — but your child's doctor should make that call first. These infections are actually uncommon in kids under 12, so it's worth confirming the diagnosis before starting treatment. And as always, keep it away from their eyes and mouth.
Is there anything I should avoid while using this?
Keep the product strictly on your skin — never swallow it, get it in your eyes, or use it inside the vagina. If it does get in your eyes, rinse thoroughly with water. The label notes that formal drug interaction studies haven't been done for oxiconazole, so if you're using other skin products on the same area, mention that to your pharmacist or doctor just to be safe.
Is Oxiconazole available over the counter?
Oxiconazole 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 Oxiconazole first available?
Oxiconazole has been available in the United States since at least 1984, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Oxiconazole?
Oxiconazole is supplied by 9 manufacturers listed in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., PharmaDerm a division of Fougera Pharmaceuticals Inc., E. Fougera & Co. a division of Fougera Pharmaceuticals Inc..

💬 Answers drafted from Oxiconazole’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 Oxiconazole comes

Oxiconazole 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 Oxiconazole Nitrate Oxistat
How this form is used
What it may be used for
  • Oxiconazole Nitrate cream treats tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm)
  • Oxiconazole Nitrate cream treats tinea (pityriasis) versicolor, a fungal infection causing skin discoloration
  • Oxiconazole Nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor
Important instructions
  • Oxiconazole Nitrate cream should be applied to the affected area and the skin immediately surrounding it once or twice daily for tinea pedis, tinea corporis, or tinea cruris
  • Oxiconazole Nitrate cream should be applied once daily for tinea (pityriasis) versicolor
  • Oxiconazole Nitrate cream: treat tinea corporis, tinea cruris, and tinea versicolor for 2 weeks; treat tinea pedis for 1 month
  • Oxiconazole Nitrate cream is for skin use only — do not use near the eyes, mouth, or inside the vagina
Available strengths 2 strengths
8 FDA-listed product records

📊 Oxiconazole across the U.S. market

How Oxiconazole 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
9
Manufacturers
2
Brand names
11
FDA-listed product records
1984
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

ANI Pharmaceuticals, Inc.18%
PharmaDerm a division of Fougera Pharmaceuticals Inc.18%
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.9%
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC9%
Harman Finochem Limited9%
Metrochem API Private Limited9%
Other makers27%

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

📈 How widely Oxiconazole is used

A general measure of how commonly Oxiconazole 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 Oxiconazole 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.

15,480
Medicaid prescriptions filled (Q1–Q4 2025)
$6.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxiconazole prescribed? Of the 1,596 medications we measure, Oxiconazole ranks #849 by Medicaid prescriptions — more than 47% of them.

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

Utilization by Oxiconazole 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 10 mg/mL topical cream is the most-dispensed Oxiconazole product — about 100% of these Medicaid prescriptions.

oxiconazole 10 MG/ML Topical Cream Most dispensed

15,465 Medicaid prescriptions (Q1–Q4 2025) 100% of Oxiconazole prescriptions shown $6.2M gross reimbursement (before rebates) ≈ $398 per prescription (gross)

Summed across the 6 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312139

oxiconazole 10 MG/ML Topical Lotion

15 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxiconazole prescriptions shown $10,814 gross reimbursement (before rebates) ≈ $721 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312140

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 Oxiconazole, 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 7 of 14 listed Oxiconazole NDCs with Medicaid activity.

🔍 Compare Oxiconazole products

A representative set of FDA-listed product records for Oxiconazole — 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/mL Topical ANI Pharmaceuticals, Inc. × 2 listings NDA View NDC →
10 mg/g Topical E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC NDA AUTHORIZED GENERIC View NDC →
10 mg/g Topical E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NDA AUTHORIZED GENERIC View NDC →
10 mg/g Topical PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA View NDC →
10 mg/mL Topical PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA View NDC →
10 mg/g Topical Sun Pharmaceutical Industries, Inc. ANDA View NDC →
10 mg/g Topical Taro Pharmaceuticals U.S.A., Inc. ANDA View NDC →
💊Bulk drug substance
25 kg/25 kg Harman Finochem Limited BULK INGREDIENT View NDC →
1 kg/kg Metrochem API Private Limited BULK INGREDIENT View NDC →
1 kg/kg Siegfried AG BULK INGREDIENT View NDC →

Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Oxiconazole 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) Oxiconazole RxCUI 32638 2 dose forms · 2 strengths
  1. Dose form (SCDF) Topical Cream RxCUI 377915 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 312139
  2. Dose form (SCDF) Topical Lotion RxCUI 377916 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 312140

Look up RxCUI 32638 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

Oxistat Oxiconazole Nitrate

🏭 Manufacturers & labelers

ANI Pharmaceuticals, Inc. 2 PharmaDerm a division of Fougera Pharmaceuticals Inc. 2 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 1 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1 Harman Finochem Limited 1 Metrochem API Private Limited 1 Siegfried AG 1 Sun Pharmaceutical Industries, Inc. 1 Taro Pharmaceuticals U.S.A., Inc. 1

RxNorm drug class

Oxiconazole belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives

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 Jan 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxiconazole.
📈
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 Oxiconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
11
Distinct labelers/manufacturers represented
9
Linked representative label
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Linked label effective
Jan 28, 2026
Composite sections available
18
Linked SPL Set ID
aa368d2b-a5d2-49dd-86e1-5693b68b46f4
Linked SPL Document ID
413f9391-fa2d-4449-b25d-fd11376f231e
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 3 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.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. E. Fougera & Co. a division of Fougera 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.