Molecule
Ketoconazole is an azole antifungal indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum, among other approved uses. MedsAcross supplies Ketoconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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), in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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 clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Source: US FDA prescribing information
Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
During clinical trials 45 (5.0%) 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 propylene glycol.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Ketoconazole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ketoconazole 2% creamTopicalGeneric name | — | US FDA | Available on request |
| Ketoconazole 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ketoconazole 20 mg/mL topical suspensionTopicalGeneric name | — | US FDA | Available on request |
| Ketoconazole 2% foamTopical Cold chainGeneric name | — | US FDA | Available on request |
| Ketoconazole 20 mg/mL shampooTopicalGeneric name | — | US FDA | Available on request |
| Ketodan 2% foamTopical Cold chain | Medimetriks Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Ketoconazole in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Ketoconazole and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ketoconazole, including Ketodan.
Yes. The US FDA first approved Ketoconazole on 12 June 1981, according to Drugs@FDA.
Yes. Ketoconazole has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Ketoconazole must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Ketoconazole is classified under ATC code D01AC08 (Ketoconazole).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.