Ketoconazole 20 mg/g Cream
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Cortisol Synthesis Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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, b...
- What exactly is tinea versicolor, and will this clear it up completely?
- 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 surfa...
- How do I actually apply this foam without making a mess?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII VTK01UQK3G
Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.303 | $4.54 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.5909 | $8.86 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3356 | $5.03 / 15 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ketoconazole 20 mg/g 00093-3219-15 | Teva | 1 tube | $0.303 | AB | Availability likely | — |
| ketoconazole 20 mg/g 00168-0099-15 | E. | 1 tube | $0.303 | AB | Availability likely | — |
| Ketoconazole 20 mg/g 16714-0955-01 | NORTHSTAR | 1 tube | $0.303 | AB | Availability likely | — |
| Ketoconazole 20 mg/gthis 21922-0025-04 | Encube | 1 tube | $0.303 | AB | Availability likely | — |
| Ketoconazole 20 mg/g 51672-1298-01 | Sun | 1 tube | $0.303 | AB | Availability likely | — |
| Ketoconazole 20 mg/g 50090-5265-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 50090-6046-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 50090-6069-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 51407-0279-15 | Golden | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 63187-0774-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 63629-8819-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 63629-8820-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 68071-1709-03 | NuCare | 30 g | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 68071-3512-05 | NuCare | 15 tubes | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 68788-8233-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 70518-4236-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Ketoconazole Cream 20 mg/g 72189-0422-30 | Direct_Rx | 30 g | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 82804-0091-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 85766-0135-15 | Sportpharm | 1 tube | — | AB | FDA listed | — |
| Ketoconazole 20 mg/g 87063-0066-15 | ASCLEMED | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 21922-0025-04 You're viewing this | 1 TUBE in 1 CARTON (21922-025-04) / 15 g in 1 TUBE | $0.3029 / g | $4.54 | 2021-05-27 | Active |
| 21922-0025-05 | 1 TUBE in 1 CARTON (21922-025-05) / 30 g in 1 TUBE | $0.2544 / g | $7.63 | 2021-05-27 | Active |
| 21922-0025-07 | 1 TUBE in 1 CARTON (21922-025-07) / 60 g in 1 TUBE | $0.1629 / g | $9.77 | 2021-05-27 | Active |
Per g, this pack runs about 86% above the cheapest pack (NDC 21922-0025-07, $0.1629 vs $0.3029 NADAC).
This pack accounts for about 15% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 21922-0025-04?
What NDC number is used to bill for this package of Ketoconazole 20 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that Ketoconazole Cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment .
Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis : Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until no clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
⛔ Contraindications ▾
CONTRAINDICATIONS Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
⚠️ Warnings ▾
WARNINGS Ketoconazole Cream, 2% is not for ophthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS During clinical trials 45 (5%) of 905 patients treated with Ketoconazole Cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol.
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Teratogenic effects Pregnancy Category C Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels. There are no adequate and well-controlled studies in pregnant women.
Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY When Ketoconazole Cream, 2% was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml. After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period. Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Ketoconazole Cream, 2%.
Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum ; yeasts: Candida albicans , Malassezia ovale (Pityrosporum ovale) and C. tropicalis ; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare) .
Only those organisms listed in the INDICATIONS AND USAGE Section have been proven to be clinically affected. Development of resistance to ketoconazole has not been reported. Mode of Action: In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.
It is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of M. ovale , but: this has not been proven.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes. 15 g tube (21922- 025-04) 30 g tube (21922- 025-05) 60 g tube (21922- 025-07) STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mfg Lic No.: 361 Manufactured by: Encube Ethicals Pvt.
Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.
Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev. 12/23
📋 Description ▾
DESCRIPTION Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous: Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: M.
Formula: C 26 H 28 Cl 2 N 4 O 4 M.W.: 531.44 Ketoconazole Structure