Full Prescribing Information

  • The safety and efficacy of this ketoconazole preparation for the treatment of fungal infections have not been established.

  • Extina┬« (ketoconazole) Foam, 2% is for topical use only and not for ophthalmic, oral, or intravaginal use. This preparation may be irritating to mucous membranes. Contact with eyes, nostrils, and mouth should be avoided.

  • Use of EXTINA Foam may result in contact sensitization, including photoallerginicity.

  • The most common adverse reactions observed in clinical trials (incidence > 1%) were application site burning (10%) and application site reaction (6%).

  • EXTINA Foam should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

  • Advise patients who are breastfeeding to exercise caution when applying this product.

  • Hepatitis and, at high doses, lowered testosterone and ACTH-induced corticosteroid serum levels have been seen with orally administered ketoconazole; however, these effects have not been seen with topical formulations.

  • The contents of EXTINA Foam are flammable; patients should avoid fire, flame, and/or smoking during and immediately following application.

EXTINA Foam is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older.