Miconazole Nitrate Vaginal Suppositories (Disposable Applicator) | Miconazole 3 Combination Pack

Miconazole nitrate (200 mg in each suppository)

Miconazole nitrate 2% (external cream)

Vaginal antifungal

For vaginal use only

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

Taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

Ask a health professional before use.

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

Other Information

NDC 37205-583-03

LEADER®

Compare to Monistat 3 active ingredient*

Miconazole 3

Combination Pack

Miconazole Nitrate Vaginal Suppositories USP, 200 mg and Miconazole Nitrate External Vulvar Cream, 2%

VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections

Relieves associated external itching and irritation

3 Vaginal suppositories with 3 disposable applicators plus external cream

NET WT. 0.32 oz (9 g) tube

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP, 200 mg and

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM, 2%

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

RELIEVES EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION

INDICATIONS

For the treatment of vaginal yeast infections and the relief of external vulvar itching and irritation associated with a yeast infection.

If you have any or all of the symptoms of a vaginal yeast infection (vaginal itching, burning, discharge) accompanied by external vulvar itching and irritation and if at some time in the past your doctor has told you that these symptoms are due to a vaginal yeast infection, then Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream should work for you. If, however, you have never had these symptoms before, you should see your doctor before using these products.

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES and MICONALZOLE NITRATE EXTERNAL VULVAR CREAM ARE FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS AND FOR THE RELIEF OF EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION. THESE PRODUCTS DO NOT TREAT OTHER INFECTIONS OR EXTERNAL ITCHING AND IRRITATION DUE TO CAUSES OTHER THAN YEAST INFECTIONS. THESE PRODUCTS DO NOT PREVENT PREGNANCY.

WHAT ARE VAGINAL YEAST INFECTIONS (CANDIDIASIS)?

A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, which is a type of yeast. Even healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can grow very quickly. In fact, the infection is sometimes called yeast (Candida) “overgrowth”.  Some women also experience a yeast infection on the external skin (vulva) associated with the internal vaginal infection.

A yeast infection can occur at almost any time of life. It is most common during the childbearing years. The infection tends to develop most often in some women who are pregnant, diabetic, taking antibiotics, taking birth control pills, or have a damaged immune system.

Various medical conditions can damage the body’s normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV – the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequently recurring vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection, or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE at 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (Hearing Impaired, TDD).

IF YOU EXPERIENCE FREQUENT YEAST INFECTIONS (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE YEAST INFECTIONS THAT DO NOT CLEAR UP EASILY WITH PROPER TREATMENT, YOU SHOULD SEE YOUR DOCTOR PROMPTLY TO DETERMINE THE CAUSE AND TO RECEIVE PROPER MEDICAL CARE.

SYMPTOMS OF VAGINAL YEAST INFECTIONS

There are many signs and symptoms of a vaginal yeast infection. They can include:

NOTE: Vaginal discharge that is different from above, for example, a yellow/green discharge or a discharge that smells “fishy”, may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using these products.

WARNINGS

CONTENTS

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP: Three vaginal suppositories each containing 200 mg of miconazole nitrate.

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM: One tube of cream for external vulvar use containing miconazole nitrate 2%.

PLASTIC APPLICATORS: Your combination pack contains either one reusable plastic applicator or three disposable plastic applicators.

DIRECTIONS FOR USE

Miconazole Nitrate Vaginal Suppositories

Begin treatment at bedtime. Before going to bed:

Miconazole Nitrate External Vulvar cream

Use the cream twice daily if needed as follows:

ADVERSE REACTIONS (SIDE EFFECTS)

The following side effects have been reported with the use of Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate External Vulvar Cream: a temporary increase in burning, itching, and/or irritation when the suppository is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using these products and consult your doctor.

FOR BEST RESULTS

IF YOU HAVE A QUESTION

1-800-432-8534 (select option #2)

Questions of a medical nature should be taken up with your doctor.

ACTIVE INGREDIENTS

MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP - miconazole nitrate (200 mg each suppository).

MICONAZOLE NITRATE EXTERNAL VULVAR CREAM – miconazole nitrate 2%.

STORAGE

Store at room temperature 59( - 86(F (15( - 30(C). Avoid heat (over 86(F or 30(C).

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road,

Lincolnton NC 28092 USA

FORM NO. 7310

Rev. 8/08

VC3336

Manufacturer

Cardinal Health, Inc.

Active Ingredients

Source

• U.S. National Library of Medicine
• DailyMed
• Last Updated: 4 May 2013