FDA-filed SPL labeling · retrieved through openFDA

Ketoconazole

Ketoconazole 2% is an antifungal treatment used on the skin to clear up tinea versicolor, a common fungal infection that causes patchy skin discoloration.

Brand names NizoralT8 Keto FlushKetodanRecorlevKuric +9 more
Drug class ⓘ Azole Antifungal
Rx/OTC Forms 5 Routes Topical · Oral
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 56 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 effectiveSep 23, 2019
Clinical labels in scope ⓘ56
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1981
FDA-listed product records ⓘ176
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
Other forms & routes:
Topical
⭐ Ketoconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ketoconazole 2% foam is an effective topical antifungal that fights tinea versicolor by breaking down the fungal cell membrane. Apply it to affected skin twice daily as directed, keep it away from flames, and be patient with pigment changes — those can take months to fully even out even after the infection is gone. If your skin reacts badly or you have any concerns, your pharmacist or doctor is always a good first call.
How we write & review this content — our editorial policy →

📖 Ketoconazole: Patient Information Guide

A plain-language walkthrough of Ketoconazole — 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▾

Ketoconazole 2% is used to treat a fungal skin infection. Here's what the label covers:

  • Tinea versicolor (pityriasis versicolor) — a yeast overgrowth on the skin that causes light or dark patches, usually on the trunk, neck, arms, or upper thighs
⚙️How it works▾

Fungi need a substance called ergosterol to keep their cell membranes strong and working. Ketoconazole blocks the enzyme (lanosterol 14α-demethylase) that the fungus uses to make ergosterol. Without it, the membrane weakens, and the fungal cell can't survive or spread.

Because human cells don't rely on ergosterol the same way, this targeted approach lets ketoconazole attack the fungus without the same effect on your own cells.

💊How it's taken▾

The 2% foam is applied to the affected skin twice daily for four weeks. Dispense the foam onto the cap of the can or another cool surface — not directly onto warm hands, where it will melt too quickly. Use your fingertips to gently rub a small amount into the skin until the foam is absorbed.

  • For hairy areas, part the hair so the foam touches the skin directly
  • Avoid getting it in your eyes or on mucous membranes
  • This product is only for use on the skin — not for eyes, mouth, or vaginal use

Always follow the specific instructions from your prescriber and the product label.

🤒Side effects — in detail▾

Most side effects from ketoconazole foam happen right at the spot where you apply it. Common ones include:

  • Burning at the application site
  • General skin reaction at the application site
  • Dryness, redness, or irritation
  • Itching or a tingling sensation
  • Warmth or a mild rash at the site

More serious reactions to watch for include signs of a skin allergy — especially a worsening or spreading rash, blistering, or a reaction triggered by sun exposure (photoallergic reaction). If any of these happen, stop using the product and contact your doctor.

⚠️Warnings & precautions▾
  • Flammable formula: The foam contains alcohol and propane/butane. Stay away from open flames, cigarettes, and any heat source while applying and right after. Don't puncture the can or store it above 120°F (49°C).
  • Contact sensitization: This product can trigger a skin allergy, including reactions made worse by sun exposure (photoallergenicity). Watch for new or worsening redness, itching, or blistering.
  • Systemic effects (not seen with topical use): When ketoconazole is taken by mouth, it has been linked to liver inflammation (hepatitis) and hormonal changes. These effects have not been seen with the topical foam, but are worth knowing if you use other ketoconazole forms.
🔀What it interacts with▾

The label does not identify specific drug or food interactions for the topical foam form of ketoconazole.

    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 if you are allergic to ketoconazole or any ingredient in this product
    • Tell your doctor if you are pregnant — animal studies with oral ketoconazole showed possible harm to developing babies; there is no human data for the foam form
    • Use caution around heat and flames — the canister contents are flammable
    • Keep out of eyes and away from mucous membranes
    🚑If you take too much▾

    The shampoo and foam are meant for external skin use only. If someone accidentally swallows ketoconazole, do not try to induce vomiting or perform gastric lavage, as this can cause aspiration (liquid entering the lungs). Seek supportive medical care and contact Poison Control or emergency services right away.

    🔬Pharmacokinetics — how your body processes it▾

    These pharmacokinetic details come from studies of the oral tablet form of ketoconazole and describe how the body handles it when swallowed. Ketoconazole needs stomach acid to dissolve and absorb properly — taking it with a meal improves absorption significantly. Antacids and acid-reducing medications (like proton pump inhibitors or H2 blockers) can sharply reduce how much of the drug gets into your system.

    Once absorbed, ketoconazole is about 99% bound to proteins in the blood and is broken down mainly by the liver enzyme CYP3A4. It leaves the body primarily through bile into the stool (about 57%), with a smaller amount in urine. It has a half-life of roughly 2 hours early on and about 8 hours later.

    📦How to store it▾

    Store at 20° to 25°C (68° to 77°F). store under refrigerated conditions. store at temperatures above 49°C (120°F).

    📄 Written from Ketoconazole’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 →

    182

    Supplements & herbs that interact with Ketoconazole

    182 supplements and herbal products have documented interactions with Ketoconazole 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 · 6
    • Moderate · 135
    • Minor · 41
    ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +174 more
    Every supplement checked against Ketoconazole — ranked by severity The full interaction hub: 6 major · 135 moderate · 41 minor · every one linked to its full report. Check Ketoconazole 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 Ketoconazole — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly is tinea versicolor, and will this clear it up completely? ▾
    Tinea versicolor is a fungal infection caused by a yeast that normally lives on everyone's skin. When it overgrows, it creates light or dark patches — most commonly on the chest, back, neck, or upper arms. Ketoconazole foam can clear the active infection, but here's the honest part: those skin color changes can stick around for months even after the fungus is gone. That's not a sign the treatment failed — it's just how your skin recovers. How quickly the color evens out depends on your skin type and how much sun you get.
    How do I actually apply this foam without making a mess? ▾
    The key is to never dispense it directly onto your hands — the foam starts melting the moment it hits warm skin. Instead, press the nozzle into the cap of the can or any cool surface, then pick up a small amount with your fingertips and gently massage it into the affected area until it's absorbed. If you're treating an area with hair, part the hair first so the foam reaches the skin directly, not just the hair. And keep it away from your eyes — it's only for use on skin.
    I smoke. Is there anything I need to know before using this? ▾
    Yes — this is actually important. The foam contains alcohol and propane/butane, which makes it flammable. You'll want to finish applying it and let it fully dry before lighting a cigarette or going near any open flame. The same goes for candles, gas stoves, or anything else that could spark. Also, don't leave the canister somewhere hot, and never puncture it.
    My skin got red and itchy after using it. Should I be worried? ▾
    Some mild burning or skin reaction at the spot you apply it is actually the most commonly reported side effect — so a little irritation isn't unusual. But if you notice a worsening rash, blistering, or a reaction that seems to get worse with sun exposure, that could be a sign of contact sensitization — basically a skin allergy to the product. In that case, stop using it and reach out to your doctor or pharmacist. Don't just push through a reaction that's spreading or getting worse.
    Will tinea versicolor come back after I finish treatment? ▾
    It can, yes — and that's not a reflection of anything you did wrong. The yeast that causes tinea versicolor is naturally part of your normal skin and doesn't go away permanently. Certain conditions can allow it to overgrow again. If you notice the patches returning, talk to your doctor about whether another course of treatment makes sense.
    I'm pregnant. Is it safe to use this? ▾
    There's no human data specifically on ketoconazole foam in pregnancy, so we genuinely don't know for certain. What the label does tell us is that in animal studies, oral ketoconazole caused some developmental concerns at higher doses. The foam is applied to the skin rather than swallowed, so much less gets into your bloodstream — but it's still wise to talk to your doctor or midwife before using it while pregnant so you can weigh the options together.
    Is Ketoconazole available over the counter? ▾
    Both — Ketoconazole is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
    When was Ketoconazole first available? ▾
    Ketoconazole has been available in the United States since at least 1981, based on FDA approval history (Drugs@FDA) and product marketing records.
    Who makes Ketoconazole? ▾
    Ketoconazole is supplied by 66 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, NuCare Pharmaceuticals,Inc..

    💬 Answers drafted from Ketoconazole’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

    📊Ketoconazole supplement interactions182 checked — ranked by severity 🌿Drug & Supplement CheckerKetoconazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ketoconazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

    💊 How Ketoconazole comes

    Ketoconazole is available in 5 forms. 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 Anti-Dandruff Anti Dandruff KetoconClear Cream Nizoral Tagrit Antifungal Treament Ketoconazole 1% Xolegel
    Available strengths 7 strengths
    10 mg/1000 g 10 mg/mL 20 mg/g 20 mg/mL 20.5 mg/mL 1 g/100 g
    Show 1 more strength Show fewer strengths
    1 g/100 mL
    89 FDA-listed product records ⓘ

    Tablet

    By mouth
    Available strengths 1 strength
    200 mg
    36 FDA-listed product records ⓘ

    Inhaler

    On the skin
    Brands Extina Ketodan
    Available strengths 2 strengths
    20 mg/g 2 g/100 g
    18 FDA-listed product records ⓘ

    Topical solution

    On the skin
    Brands Anti Dandruff Cysndra Ketoconazole 1% Medicated Shampoos Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos Gembooxt Ketoconazole 1% Medicated Shampoos
    Available strengths 2 strengths
    1 mg/100 mg 0.01 g/mL
    5 FDA-listed product records ⓘ

    Oral solution

    By mouth
    Available strengths 1 strength
    10.2 mg/mL
    1 FDA-listed product record ⓘ

    📊 Ketoconazole across the U.S. market

    How Ketoconazole 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.

    5
    Dose forms ⓘ
    66
    Manufacturers
    14
    Brand names
    176
    FDA-listed product records ⓘ
    1981
    First marketed ⓘ

    FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

    Also listed with the FDA, not a patient dose form: Powder (26) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

    Bryant Ranch Prepack16%
    A-S Medication Solutions10%
    NuCare Pharmaceuticals,Inc.5%
    Remedyrepack Inc.5%
    Kramer Laboratories5%
    Padagis Israel Pharmaceuticals Ltd4%
    Other makers55%

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

    📈 How widely Ketoconazole is used

    A general measure of how commonly Ketoconazole 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 Ketoconazole 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.

    2,593,228
    Medicaid prescriptions filled (Q1–Q4 2025)
    $57.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Ketoconazole prescribed? Of the 1,596 medications we measure, Ketoconazole ranks #89 by Medicaid prescriptions — more than 94% of them.

    Where Ketoconazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #89 of 1,596
    #84 Furosemide 2,765,096 Rx #85 Prednisolone 2,763,880 Rx #86 Mirtazapine 2,693,128 Rx #87 Sodium Chloride 2,643,128 Rx #88 Methylprednisolone 2,620,269 Rx #89 Ketoconazole 2,593,228 Rx #90 Ketoconazole Topical 2,579,373 Rx #91 Olanzapine 2,565,436 Rx #92 Naproxen 2,556,513 Rx #93 Methylprednisolone Inj... 2,550,742 Rx #94 Spironolactone 2,528,169 Rx

    Utilization by Ketoconazole 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 medicated shampoo is the most-dispensed Ketoconazole product — about 64% of these Medicaid prescriptions.

    ketoconazole 20 MG/ML Medicated Shampoo Most dispensed

    1,650,837 Medicaid prescriptions (Q1–Q4 2025) 64% of Ketoconazole prescriptions shown $28.5M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

    Summed across the 5 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 106336

    ketoconazole 20 MG/ML Topical Cream

    928,536 Medicaid prescriptions (Q1–Q4 2025) 36% of Ketoconazole prescriptions shown $17.3M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

    Summed across the 16 of 50 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 203088

    ketoconazole 20 MG/ML Topical Foam

    7,103 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketoconazole prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $364 per prescription (gross)

    Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 728550

    ketoconazole 200 MG Oral Tablet

    6,436 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketoconazole prescriptions shown $153,534 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

    Summed across the 4 of 70 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197853

    levoketoconazole 150 MG Oral Tablet

    316 Medicaid prescriptions (Q1–Q4 2025) <1% of Ketoconazole prescriptions shown $8.8M gross reimbursement (before rebates) ≈ $27,837 per prescription (gross)

    Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2588848

    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 Ketoconazole, 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 31 of 159 listed Ketoconazole NDCs with Medicaid activity.

    🔍 Compare Ketoconazole products

    A representative set of FDA-listed product records for Ketoconazole — 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.)

    Showing 176 of 176 products — FDA National Drug Code Directory. See every product, package size and price: browse all 176 Ketoconazole 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) Ketoconazole RxCUI 6135 8 dose forms · 11 strengths
    1. Dose form (SCDF) Medicated Bar Soap RxCUI 2721935 In current FDA listings
      Clinical drug / strength (SCD) 0.01 MG/MG RxCUI 2721936
    2. Dose form (SCDF) Medicated Shampoo RxCUI 377504 In current FDA listings
      Clinical drug / strength (SCD) 5 MG/ML RxCUI 425918 10 MG/ML RxCUI 240812 20 MG/ML RxCUI 106336
    3. Dose form (SCDF) Oral Tablet RxCUI 372533 In current FDA listings
      Clinical drug / strength (SCD) levoketoconazole 150 MG RxCUI 2588848 200 MG RxCUI 197853
    4. Dose form (SCDF) Otic Solution RxCUI 2609846 No current FDA listing
      Clinical drug / strength (SCD) 2 MG/ML RxCUI 2609847
    5. Dose form (SCDF) Topical Cream RxCUI 377736 In current FDA listings
      Clinical drug / strength (SCD) 20 MG/ML RxCUI 203088
    6. Dose form (SCDF) Topical Foam RxCUI 728549 In current FDA listings
      Clinical drug / strength (SCD) 20 MG/ML RxCUI 728550
    7. Dose form (SCDF) Topical Gel RxCUI 441005 In current FDA listings
      Clinical drug / strength (SCD) 0.02 MG/MG RxCUI 647253
    8. Dose form (SCDF) Topical Solution RxCUI 1297959 In current FDA listings
      Clinical drug / strength (SCD) 1 MG/ML RxCUI 1297960

    Look up RxCUI 6135 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

    Nizoral T8 Keto Flush Ketodan Recorlev Kuric Xolegel Extina Anti Dandruff Anti-Dandruff Gembooxt Ketoconazole 1% Medicated Shampoos Tagrit Antifungal Treament Ketoconazole 1% Cysndra Ketoconazole 1% Medicated Shampoos Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos KetoconClear Cream

    🏭 Manufacturers & labelers

    Bryant Ranch Prepack 24 A-S Medication Solutions 15 NuCare Pharmaceuticals,Inc. 8 Remedyrepack Inc. 7 Kramer Laboratories 7 Padagis Israel Pharmaceuticals Ltd 6 Guangzhou ChuanMa International Trading Co.,Ltd. 6 PD-Rx Pharmaceuticals, Inc. 4 Preferred Pharmaceuticals, Inc. 4 Medimetriks Pharmaceuticals, Inc. 4 Preferred Pharmaceuticals Inc. 4 Golden State Medical Supply, Inc. 4 Direct_Rx 4 Northstar Rx Llc 3 Tagrid Llc 3 Taro Pharmaceuticals U.S.A., Inc. 3 Strides Pharma Science Limited 3 Thirty Madison Inc 3 Direct Rx 3 RPK Pharmaceuticals, Inc. 3 Guangzhou Xinhongda Trading Service Co., Ltd. 2 Xiromed, LLC 2 Quimica Sintetica S.A. 2 Letco Medical, Llc 2

    …and 16 more on the FDA NDC directory.

    RxNorm drug class

    Ketoconazole belongs to the Cortisol Synthesis Inhibitor class.

    Pharmacologic class Cortisol Synthesis Inhibitor, Azole Antifungal
    Drug family (ATC) Anticorticosteroids, Imidazole and triazole derivatives, Imidazole derivatives
    How it works Cytochrome P450 2B6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 17A1 Inhibitors, P-Glycoprotein Inhibitors

    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 Sep 23, 2019
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ketoconazole.
    📈
    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 Ketoconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    56
    NDC products indexed
    176
    Distinct labelers/manufacturers represented
    66
    Linked representative label ⓘ
    Xiromed, LLC
    Linked label effective
    Sep 23, 2019
    Composite sections available
    22
    Linked SPL Set ID
    ea319889-5e58-f778-3009-5ba6a5f2690a
    Linked SPL Document ID
    1d2842b4-06d6-8054-d485-cb30f0ed4f69
    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 56 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. Xiromed, 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.