Tioconazole is an antifungal medication that fights infections caused by fungus.

Vagistat-1 (for use in the vagina) is used to treat vaginal Candida (yeast) infections.

Vagistat-1 may also be used for other purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take Vagistat-1 by mouth. It is for use only in your vagina.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is usually given as a single dose. You should notice some improvement in your symptoms after the 1-day treatment. It may take up to 7 days after using the 1-day dose before your symptoms go away completely.

Call your doctor if your symptoms do not improve after 3 days, or if you still have symptoms for longer than 7 days. Frequent vaginal yeast infections that do not clear up with treatment may be a sign of a more serious condition.

The single-use applicator is for one use only. Throw the applicator away after one use, even if there is still some medicine left in it after inserting your dose.

Vagistat-1 contains mineral oil or petrolatum, which can weaken the latex rubber in a condom or diaphragm. These forms of birth control may be less effective if you use them during your treatment with this medicine. Use another form of birth control while you are using tioconazole and for at least 3 full days after your treatment ends.

Store at room temperature away from moisture and heat. Do not warm the medicine applicator before using Vagistat-1.

You should not use Vagistat-1 if you are allergic to it.

Do not use Vagistat-1 if you have never had a vaginal yeast infection that has been confirmed by a doctor.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• fever, chills, vomiting, pain in your back or shoulder;

• pelvic pain, vaginal discharge with a bad odor;

• if you are having vaginal itching or discomfort for the first time; or

• if you think you may have been exposed to HIV (human immunodeficiency virus).

FDA pregnancy category C. It is not known whether Vagistat-1 will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

It is not known whether tioconazole vaginal passes into breast milk or if it could harm a nursing baby. Do not use this medicine without your doctor's advice if you are breast-feeding.

Do not give this medication to anyone under 12 years old without medical advice.

Since Vagistat-1 is used as a single dose, it does not have a daily dosing schedule.

Since Vagistat-1 is used as a single dose from a prefilled applicator, an overdose is unlikely to occur.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Do not use a tampon, vaginal douche, spermicide, or other vaginal products while you are using Vagistat-1. Do not have vaginal intercourse during treatment.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects of Vagistat-1 may include:

• vaginal redness or swelling;

• mild stomach pain;

• pain or burning when you urinate;

• headache, runny or stuffy nose; or

• mild vaginal burning, itching or irritation after use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.