WARNINGS
Naftin® Cream, 1% is for topical use only and not for ophthalmic use.
PRECAUTIONS
General
Naftin® Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® Cream, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.
Information for patients
The patient should be told to:
- Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
- Keep Naftin® Cream, 1% away from the eyes, nose, mouth and other mucous membranes.
Carcinogenesis, mutagenesis, impairment of fertility
Long-term animal studies to evaluate the carcinogenic potential of Naftin® Cream, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.
Pregnancy
Teratogenic Effects
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftin® Cream, 1% is administered to a nursing woman.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
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