Ketoconazole Cream

  • Skin infections (topicals)

Ketoconazole Cream Generic Name & Formulations

General Description

Ketoconazole 2%; may contain sulfites.

Pharmacological Class

Azole antifungal.

How Supplied

Crm—contact supplier


Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15° C to 30° C (59° F to 86° F.)

Mechanism of Action

Ketaconozole is a boad spectrum synthetic anti-fungal agent which inhibits the in vitro growth of certain dermatophytes and yeasts by altering the permeability of the cell membrane. Studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.

Ketoconazole Cream Indications


Tinea corporis, t. cruris, t. versicolor, t. pedis, cutaneous candidiasis, seborrheic dermatitis.

Ketoconazole Cream Dosage and Administration


Apply once daily to affected and adjacent area. Treat for at least 2 weeks. T. pedis: treat for 6 weeks. Seborrheic dermatitis: apply to affected area twice daily for 4 weeks or until clinical clearing. Reevaluate if no improvement after full course of treatment.


Not recommended.

Ketoconazole Cream Contraindications

Not Applicable

Ketoconazole Cream Boxed Warnings

Not Applicable

Ketoconazole Cream Warnings/Precautions


Asthma. Discontinue if sensitization occurs. Avoid eyes. Pregnancy (Cat.C). Nursing mothers: not recommended.



  • Ketoconazole 2% cream is not for ophthalmic use.
  • Some Ketoconazole 2% cream formulations may contain sodium sulfite anhydrous, a sulfite that can cause allergic-type reactions, including anaphylactic symptoms, and life-threatening or less severe asthmatic episodes in certain susceptible patients.
  • Sulfite sensitivity is seen more frequently in asthmatic versus nonasthmatic patients.
  • Discontinue therapy if a reaction suggesting sensitivity or chemical irritation should occur.

Pregnancy Considerations

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.

Nursing Mother Considerations

Given topically, it is not known whether ketoconazole cream could result in sufficient systemic absorption to produce detectable quantities in breast milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Considerations

Safety and effectiveness in children have not been established.

Ketoconazole Cream Pharmacokinetics





Ketoconazole Cream Interactions

Ketoconazole Cream Adverse Reactions

Adverse Reactions

Irritation, pruritus, stinging, allergic reaction. 

Ketoconazole Cream Clinical Trials

See Literature

Ketoconazole Cream Note


Formerly known under the brand names Ketozole, Nizoral.

Ketoconazole Cream Patient Counseling

See Literature