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

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

Butoconazole vaginal 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.

butoconazole vaginal is usually given as a single dose. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take butoconazole vaginal by mouth. It is for use only in your vagina.

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

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.

Call your doctor if your symptoms do not improve, or if your infection goes away and comes back. Frequent vaginal yeast infections that do not clear up with treatment may be a sign of a more serious condition.

Butoconazole vaginal contains mineral oil, 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 butoconazole vaginal. Use another form of birth control while you are using butoconazole 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 butoconazole vaginal.

Usual Adult Dose for Vaginal Candidiasis:

Insert 1 applicatorful intravaginally once.

Use: For the local treatment of vulvovaginal candidiasis

You should not use butoconazole vaginal if you are allergic to it.

To make sure butoconazole vaginal is safe for you, tell your doctor about all your medical conditions.

It is not known whether butoconazole vaginal will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether butoconazole vaginal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

Since butoconazole vaginal is used as a single dose, it does not have a daily dosing schedule.

Since butoconazole vaginal 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.

Avoid using other vaginal products at the same time as butoconazole vaginal, unless your doctor tells you to.

Get emergency medical help if you have 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 butoconazole vaginal may include:

• pelvic pain or cramps;

• vaginal burning or itching;

• vaginal pain and swelling; or

• mild vaginal 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.