Drug Information Update - FDA Office of Generic Drugs approves first generic for Oxistat (oxiconazole nitrate) Cream, 1%

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The U.S. Food and Drug Administration approved a first generic for Oxistat (oxiconazole nitrate) Cream, 1%  for the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum) and tinea (pityriasis) versicolor due to Malassezia furfur. 

The most common side effects reported by people using oxiconazole nitrate cream in clinical trials included pruritis, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging, and nodules.

Oxistat cream must be dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks. Oxistat cream must be used as directed by the physician and is for external dermal use only. The hands should be washed after applying the medication. Avoid contact with the eyes, nose, mouth, vagina, and other mucous membranes. Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after two to four weeks, or sooner if the condition worsens or if the area of application shows signs of increased irritation, itching, blistering, swelling or oozing.

More information on oxiconazole nitrate cream, 1% may be found within the drug label. Search Drugs@FDA for drug labels of FDA approved drug products.