tioconazole 1

Rite Aid Corporation

Rite Aid Corporation Tioconazole 1 Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each applicator)
• Purpose
• Use
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• tioconazole 1 Other information
• Inactive ingredients
• Questions or comments?
• Consumer Information
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each applicator)

Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Use

• •treats vaginal yeast infections

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

• • vaginal itching and discomfort for the first time
• •lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• •vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• •been exposed to human immunodeficiency virus (HIV) that causes AIDS

When using this product

• •do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
• •do not have vaginal intercourse
• •mild increase in vaginal burning, itching or irritation may occur

Stop use and ask a doctor if

• •symptoms do not get better after 3 days
• •symptoms last more than 7 days
• •you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• •before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
• •adults and children 12 years and over:
• •open the foil packet just before use and remove purple cap
• •insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
• •children under 12 years of age: ask a doctor

tioconazole 1 Other information

• •this product is a 1-dose treatment, most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
• •if you have questions about vaginal yeast infections, consult your doctor
• •store at 20° - 25°C (68° - 77°F)
• •see end flap of carton for lot number and expiration date

Inactive ingredients

butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions or comments?

1-800-719-9260

Consumer Information

1-DOSE TREATMENT

Tioconazole Ointment 6.5%

VAGINAL ANTIFUNGAL

EDUCATIONAL BROCHURE

Please read this educational brochure completely before using this product.

USE: treats vaginal yeast infections

1 THIS PRODUCT CURES MOST RECURRENT VAGINAL YEAST INFECTIONS

IF THIS IS THE FIRST TIME YOU HAVE HAD VAGINAL ITCH AND DISCOMFORT, CONSULT YOUR DOCTOR. IF YOU HAVE HAD A DOCTOR DIAGNOSE A VAGINAL YEAST INFECTION BEFORE AND HAVE THE SAME SYMPTOMS NOW, USE THIS OINTMENT AS DIRECTED. THIS PRODUCT IS FOR THE TREATMENT OF RECURRENT VAGINAL YEAST INFECTIONS ONLY. IT DOES NOT TREAT OTHER INFECTIONS AND DOES NOT PREVENT PREGNANCY.

This product, a vaginal ointment that contains an antifungal medicine, works to cure most recurrent vaginal yeast infections by killing the overgrowth of yeast.

2 WHAT IS A VAGINAL YEAST INFECTION (CANDIDIASIS)?

A yeast infection is caused by an organism called Candida, which is a type of yeast. Healthy women usually have this yeast in the vagina. Either an overgrowth or rapid growth of this yeast can cause a vaginal yeast infection. The symptoms of a vaginal yeast infection can include any or all of the following:

■ Vaginal itching - Itching can range from mild to intense.

■ Vaginal discharge - This discharge may be thick like paste or lumpy like cottage cheese.

■ Vaginal soreness, burning or irritation – The vagina can feel sore inside or there can be a burning sensation, particularly during vaginal intercourse.

■ Rash or redness - Rash or redness may occur around the vagina (vulvar irritation).

NOTE: Vaginal discharge that is different from the above, for example, a yellow/green discharge or a discharge that smells "fishy" (foul-smelling), may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using this product.