Ketoconazole
20 mg/g · Cream
- Prescription only
- Azole Antifungal
- Active substance
- Ketoconazole
- Made by
- Golden State Medical Supply, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-07-10
Azole Antifungal
- 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…
Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2025-07-10 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-07-10
Do not take it if
Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Ketoconazole cream, 2% is not for ophthalmic use.
- General If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
- Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.
- Carcinogenesis, Mutagenesis, Impairment of Fertility A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.
- The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development.
- The Ames' salmonella microsomal activator assay was also negative.
- 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).
- Nursing Mothers It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk.
- Pediatric Use Safety and effectiveness in children have not been established.
- General If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
- Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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.
- It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk.
- Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and effectiveness in children have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
- 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Ketoconazole cream, 2% is supplied in 15 g (NDC 51407-279-15), 30 g (NDC 51407-279-30), and 60 g (NDC 51407-279-60) tubes.
- Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Quoted from the official label, section “How Supplied”.
How to store it
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Quoted from the official label, section “Storage and Handling”.
What is in it
- Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.
- Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula:
- Molecular Formula:
- C 26 H 28 Cl 2 N 4 O 4 Molecular Weight:
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (23)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 23 of 23
- KetoconazoleThis onePrescription onlyGolden State Medical Supply, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- KetoconazolePrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- KetoconazolePrescription onlyANI Pharmaceuticals, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- KetoconazolePrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- KetoconazolePrescription onlyCosette Pharmaceuticals, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNo ingredient list on the stored label
- KetoconazolePrescription onlyNorthstar Rx LLCNo ingredient list on the stored label
- KetoconazolePrescription onlyNORTHSTAR RX LLCNo ingredient list on the stored label
- KetoconazolePrescription onlyNuCare Pharmaceuticals, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyPadagis Israel Pharmaceuticals LtdNo ingredient list on the stored label
- KetoconazolePrescription onlyPreferred Pharmaceuticals Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyProficient Rx LPNo ingredient list on the stored label
- KetoconazolePrescription onlyProficient Rx LPNo ingredient list on the stored label
- KetoconazolePrescription onlySun Pharmaceutical Industries, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyTeva Pharmaceuticals USA, Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyTHIRTY MADISON INCNo ingredient list on the stored label
- KetoconazolePrescription onlyTOLMAR Inc.No ingredient list on the stored label
- KetoconazolePrescription onlyViona Pharmaceuticals IncNo ingredient list on the stored label
- KetoconazolePrescription onlyZydus Lifesciences LimitedNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Golden State Medical Supply, Inc. |
|---|---|
| Active substance | Ketoconazole |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 20 mg/g |
| Form | Cream |
| Route | Topical |
| Packs | 1 TUBE in 1 CARTON / 15 g in 1 TUBE · 1 TUBE in 1 CARTON / 30 g in 1 TUBE |
| NDC | 51407-279 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
42 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Cream14 products
20 mg/g14
20 mg/g · 14 companies
- A-S Medication Solutions
- ASCLEMED USA INC.
- Bryant Ranch Prepack
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Encube Ethicals, Inc.
- Golden State Medical Supply, Inc. · this page
- NORTHSTAR RX LLC
- NuCare Pharmaceuticals,Inc.
- Shampoo, Suspension11 products
- Tablet11 products
- Aerosol, Foam3 products
2 g/100g2
2 g/100g · 2 companies
- 20 mg/g
Show all forms · 5 forms
- Shampoo3 products
20 mg/mL3
20 mg/mL · 3 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.