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Miconazole Nitrate


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Miconazole nitrate USP 4%


Purpose

Vaginal antifungal


Use

  • treats vaginal yeast infections

Warnings

For vaginal use only


OTC - DO NOT USE SECTION

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 the human immunodeficiency virus (HIV) that causes AIDS

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.


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 diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

  • symptoms do not get better in 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions

  • before using this product read the enclosed consumer information leaflet for complete directions and information
  • adults and children 12 years of age and over: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

Other information

  • do not use if seal over tube opening has been punctured
  • do not purchase if carton is open
  • store at 20° to 25°C (68° to 77°F)
  • see end flaps of carton and end of tube for lot number and expiration date

Inactive ingredients

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.


Questions?

call 1-866-923-4914


SPL UNCLASSIFIED SECTION

Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532


SPL UNCLASSIFIED SECTION

Consumer Information Leaflet

Miconazole 3 Miconazole Nitrate Vaginal Cream USP (4%) Vaginal Antifungal

Cures Most Vaginal Yeast Infections

Why should I use Miconazole Nitrate Vaginal Cream USP (4%)?

Miconazole Nitrate Vaginal Cream USP contains 4% miconazole nitrate cream that cures most vaginal yeast infections. Do not use miconazole nitrate vaginal cream USP (4%) if this is the first time you have vaginal discharge, itching, burning and discomfort. See your doctor or health professional firstto find out the cause of your symptoms. If a doctor has told you in the past that you had a vaginal yeast infection and you have the same symptoms now (such as vaginal discharge, itching or burning), then miconazole nitrate vaginal cream USP (4%) may work for you.

What is a vaginal yeast infection?

A vaginal yeast infection is a common condition caused by an overgrowth of yeast (Candida) that may normally live in the vagina. Your doctor may call this infection "monilia" or "candidiasis." Some women may have a yeast infection on the skin outside of the vagina (vulva) at the same time that they have a vaginal infection.

Who can get a vaginal yeast infection?

You can get a vaginal yeast infection at any age. It is most common during the childbearing years. Women who are pregnant or diabetic, taking antibiotics, birth control pills or steroids, or who have a weakened immune system are more likely to get repeated yeast infections that may not clear up easily with proper treatment.

Some medical conditions can weaken the body's normal ability to fight infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV – the virus that causes AIDS). The HIV virus causes the body to be more likely to get infections, including vaginal yeast infections that may not clear up easily with proper treatment. If you may have been exposed to HIV and get repeated vaginal yeast infections, you should see your doctor right away. For more information on HIV infection, please contact your doctor or the CDC National AIDS HOTLINE. The CDC phone number is: 1-800-232-4636 (English and Spanish), or 1-888-232-6348 (hearing impaired, TDD).

How can I tell if I have a vaginal yeast infection?

When you have a vaginal yeast infection, you may have one or more of the following symptoms:

Note: Vaginal yeast infections do NOT cause fever, chills, lower abdominal, back or shoulder pain, foul-smelling vaginal discharge, or a missed period. These may be signs of a sexually transmitted disease (STD) or a tubal pregnancy. If you have these symptoms, call your doctor right away.

What are other causes of a vaginal discharge?

It is normal to have a small amount of vaginal discharge at certain times of the month. This normal discharge may be clear or slightly white and does not cause itching, pain or a foul odor.

The most common cause of an abnormal vaginal discharge is an infection. These infections include bacterial vaginosis (BV), trichomoniasis (Trich), gonorrhea (GC) and/or chlamydia. All of these may be transmitted sexually and are called sexually transmitted diseases (STDs). If you have more questions about sexually transmitted diseases (STDs) call the CDC STD Hotline at 1-800-227-8922.

Although many of the infections mentioned above can cause symptoms similar to a vaginal yeast infection (vaginal discharge, irritation and itching), their diagnosis must be made by a doctor so that proper treatment can be given.

If these infections are not properly treated or if proper treatment is delayed, serious problems, such as pelvic inflammatory disease (PID) may result, which may prevent you from having children in the future. If you are pregnant and do not get the proper treatment, the infection may be passed to your baby before or during delivery and may cause your baby to have permanent damage. If you have multiple sex partners or a new sex partner, you should also ask a doctor before use to make sure you do not have an STD.

Why do women get repeated vaginal yeast infections?

Women may get repeated vaginal yeast infections that may not clear up easily with proper treatment. Listed below are some of the causes of repeated yeast infections:

If you get vaginal yeast infections often (such as once a month or 3 in 6 months), you should talk to a doctor.

Are vaginal yeast infections sexually transmitted?

Vaginal yeast infections are usually not spread by having intercourse (sex). However, if your partner has a rash, itching or discomfort in his genital area, he should contact a doctor to find out the cause of his symptoms and tell the doctor that you are treating your vaginal yeast infection with miconazole nitrate vaginal cream USP (4%).

How can I prevent repeated vaginal yeast infections?

To lower your chances of getting another yeast infection:

Can I use Miconazole Nitrate Vaginal Cream USP (4%) during my menstrual period?

Yes, this product can be used during your menstrual period. In fact, many women get vaginal yeast infections just before their period because of hormonal changes. Using miconazole nitrate vaginal cream during your period will not affect how well this product works. If you have started treatment and your period occurs, you should complete the full course of treatment.

Do not use tampons while using this product, because tampons may remove some of the drug from the vagina. Use deodorant-free sanitary napkins or pads instead, and change them often.

Can I use other vaginal products with Miconazole Nitrate Vaginal Cream USP (4%)?

This drug should notbe used with other vaginal products.

How can I get the best results when treating my infection?

What warnings should I know about when using Miconazole Nitrate Vaginal Cream USP (4%)?

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:

Ask a doctor or pharmacist before use ifyou are taking the prescription blood thinning medicine, warfarin (coumadin), because bleeding or bruising may occur.

When using this product:

Stop use and ask your doctor if:

If pregnant or breastfeeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

What side effects may occur with Miconazole Nitrate Vaginal Cream USP (4%)?

A mild increase in vaginal burning, itching, or irritation may occur when the applicator containing the cream is inserted. Abdominal cramping has also been reported.

Stop using miconazole nitrate vaginal cream USP (4%) and consult your doctor if you have abdominal pain, hives, skin rash, or if you have severe vaginal burning, itching, or irritation or swelling.

What should I do if I have questions about Miconazole Nitrate Vaginal Cream USP (4%)?

Questions of a medical nature should be taken up with your doctor. If you have any other questions or need more information on this product, call 1-866-923-4914.

Other information:

Active ingredient:miconazole nitrate USP 4%.

Inactive ingredients:cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol.

How should I use Miconazole Nitrate Vaginal Cream USP (4%) with 3 disposable applicators?

This product is for adults and children 12 years of age and over. For children under 12 years, ask a doctor.

Directions for using the vaginal cream:

Begin treatment before going to bed:

Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Made in Canada

LPK-5199-3 0220-3 35

  • vaginal itching
  • vaginal discharge that may be thick, white, and lumpy like cottage cheese
  • vaginal soreness, irritation, or burning
  • rash or redness on the skin outside the vagina (vulva)
  • burning on urination
  • painful vaginal intercourse (sex)