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INDICATIONS AND USAGE: NAFTIN (naftifine hydrochloride) GEL 2% is an allylamine antifungal indicated for the treatment of athlete’s foot between the toes caused by fungus in patients 12 years of age and older.
WARNING: If there is redness or irritation on the skin with the use of NAFTIN GEL 2%, stop treatment and speak with your doctor.
INFORMATION FOR PATIENTS:
1. NAFTIN GEL 2% is only for use on top of the skin. NAFTIN GEL 2% should not be used in the mouth, eyes, or vagina.
2. If there is irritation or redness with the use of NAFTIN GEL 2%, treatment should be stopped. Contact your doctor if you have irritation or redness on the skin after using NAFTIN GEL 2%.
Cancer Risk: It is not known whether NAFTIN causes cancer or causes a risk of cancer. Long-term studies to evaluate the risk of cancer from NAFTIN GEL 2% have not been done.
Pregnancy: Let your doctor know if you are pregnant or plan to become pregnant. NAFTIN GEL 2% should be used during pregnancy only if the benefit to the mother is greater than the risk to the unborn baby.
Nursing Mothers: It is not known whether this drug passes into breast milk. Because many drugs pass into breast milk, women who are nursing should take care when using NAFTIN GEL 2%.
Pediatric Use: Safety and effectiveness in children under 12 years old has not been proven.
SIDE EFFECTS: In clinical trials with NAFTIN GEL 2%, the most common side effect was itching on the skin where the medicine was applied.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
REFERENCES: 1. Vlahovic TC. Choosing the right vehicle. Podiatr Manage. June/July 2008;209-218. 2. Data on file, Legacy Pharma Inc.