Active Ingredient

Clotrimazole 1%

Inactive Ingredients

Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters Wax, 2-Octyldodecanol, Polysorbate 60, Purified Water, Sodium Phosphate Monobasic, and Sorbitan Monostearate.

Clotrimazole Vaginal Cream will cure most vaginal yeast (candida) infections.

Clotrimazole Vaginal Cream can kill the yeast that cause vaginal yeast infections and can relieve the associated itching and burning.

Directions

Fill the applicator with the cream and then insert one applicatorful of cream into the vagina every day, preferably at bedtime. Dispose of applicator after use.

Repeat this procedure with a new applicator for 7 consecutive days. For relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching.

THE CREAM SHOULD NOT BE USED FOR VULVAR ITCHING DUE TO CAUSES OTHER THAN A YEAST INFECTION.

Important: In order to kill the yeast completely, you must use CLOTRIMAZOLE VAGINAL CREAM the full seven days, as instructed above, even if your symptoms are relieved sooner.

See carton and tube crimp for lot number and expiration date.

Store at room temperature between 2°-30°C (36°-86°F).

No information provided.

†Do not use if you have abdominal pain, fever, or a foul-smelling vaginal discharge. You may have a condition which is more serious than a yeast infection. Contact your doctor immediately.

†Do not use if this is your first experience with vaginal itch and discomfort. See your doctor.

†If there is no improvement within 3 days, you may have a condition other than a yeast infection. Stop using this product and see your doctor.

†If you may have been exposed to the human immunodeficiency virus (HIV, the virus that causes AIDS) and are now having recurrent vaginal yeast infections, especially infections that don†t clear up easily with proper treatment, see your doctor promptly to determine the cause of your symptoms and to receive proper medical care.

†If symptoms recur within a 2 month period, contact your doctor.

†Do not use during pregnancy except under the advice and supervision of a doctor.

†This medication is for use in the vaginal and vulvar areas only. It is not for use in the mouth or the eyes. In case accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

† Keep this and all drugs out of reach of children. This product is not to be used in children less than 12 years of age.

If you have questions about Clotrimazole Vaginal Cream or vaginal yeast infections, contact your doctor.

No information provided.

See PATIENT INFORMATION section.

No information provided.

No information provided.

HOW TO RECOGNIZE A RECURRENT YEAST INFECTION OF THE VAGINAL AND VULVAR AREA.

Clotrimazole Vaginal Cream will cure most vaginal yeast (candida) infections. But not every vaginal infection is caused by yeast. If this is the first time you are experiencing vaginal itch and discomfort, or if you are experiencing external vulvar itch, it is important to visit your doctor to be sure that yeast is the problem. Do not use if you have abdominal pain, fever, or foul-smelling vaginal discharge. You may have a condition more serious than a yeast infection, and you should see your doctor immediately.

The main symptom of a vaginal yeast infection is itching which can be moderate to intense. The itching is usually in the folds of the vagina and on the external skin (vulva) around the vagina. Yeast infection may also cause a white discharge from the vagina. The discharge may be thick like paste or lumpy like cottage cheese. Underneath the discharge, the irritated skin of the vulva may be swollen, cracked and red, or may have small red sore spots. The vagina may also feel sore inside or have a burning sensation, particularly during vaginal intercourse.

If you have one or more of these symptoms, especially in the days before your period, you could have a vaginal yeast infection.

CLOTRIMAZOLE VAGINAL CREAM CAN KILL THE YEAST THAT CAUSES THE INFECTION.

To cure a vaginal yeast infection, it is necessary to eliminate the yeast cells. Clotrimazole Vaginal Cream can kill the yeast that cause vaginal yeast infections and can relieve the associated itching and burning.

HOW TO USE

Fill the applicator with the cream and then insert one applicatorful of cream into the vagina every day, preferably at bedtime. Dispose of applicator after use.

Repeat this procedure with a new applicator for 7 consecutive days. For relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching.

THE CREAM SHOULD NOT BE USED FOR VULVAR ITCHING DUE TO CAUSES OTHER THAN A YEAST INFECTION.

Important: In order to kill the yeast completely, you must use CLOTRIMAZOLE VAGINAL CREAM the full seven days, as instructed above, even if your symptoms are relieved sooner.

To load the applicator

Remove cap from tube of cream. Screw open end of applicator onto tube of cream. Gently squeeze opposite end of tube, forcing cream into barrel of applicator. The plunger will stop moving outward when the barrel contains the proper amount of cream. When the barrel is full, unscrew applicator from tube. After each use, replace cap and roll up the tube from the bottom.

To insert the vaginal cream:

Lie on your back with your knees bent. Insert the open end of the filled applicator into the vagina as deeply as it will go comfortably. Holding the applicator in place with thumb and middle finger, press the plunger until it stops. Withdraw the applicator.

IMPORTANT: Insert one applicatorful of CLOTRIMAZOLE VAGINAL CREAM each day for the full 7 days.

CLOTRIMAZOLE VAGINAL CREAM usually starts to relieve itching and other symptoms within 3 days. If you do not improve in 3 days or if you do not get well in 7 days, you may have a condition other than a vaginal yeast infection. Discontinue use of the product and consult your doctor. Also, if symptoms recur within a 2 month period, contact your doctor.

During your period, continue to use CLOTRIMAZOLE VAGINAL CREAM. Its action is not affected by menstruation. However, DO NOT USE TAMPONS WHILE THE MEDICINE IS IN USE: sanitary napkins may be used instead.

The vagina normally has a mixture of two kinds of germs called bacteria and yeast. Under certain conditions, the yeast in the vagina can grow too much † causing vaginal itching, vulvar irritation, and often, a discharge. In some women, the conditions that allow the yeast to multiply can include the use of certain birth control pills, routine hormonal changes, or taking antibiotics. Pregnancy and diabetes are two other important conditions that can lead to vaginal yeast infections. In women with frequently recurrent vaginal yeast infections, especially infections that don†t clear up easily with proper treatment, the vaginal yeast infections may also be the result of serious medical conditions, including infection with HIV (the virus that causes AIDS), that can damage the body†s normal defenses against infection.

Hormonal changes are sometimes the cause.

Hormonal changes can cause some women to be prone to yeast infections. Some women get vaginal yeast infections during pregnancy, while taking certain birth control pills, or every month just before their period.

Antibiotics are sometimes the cause.

Killing the normal bacteria of the vagina may allow yeast to multiply. That is why women taking antibiotics are more likely to get vaginal yeast infections.

Damage to the body†s normal defenses against infection is sometimes the cause.

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 VAGINAL YEAST INFECTIONS (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE VAGINAL 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.

Men usually do not get or spread yeast infections through sexual intercourse. However, if a woman†s yeast infections keep recurring, she should ask her partner to seek evaluation by a doctor.

Cotton underpants may help.

Yeast flourish in a warm, moist environment. Since tight synthetic underpants and pantyhose can increase heat and moisture in the area of the vulva, it is probably better to wear cotton underpants if you are prone to vaginal yeast infections and vulvar irritation.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CLOTRIMAZOLE - VAGINAL

(kloh-TRIM-uh-zole)

COMMON BRAND NAME(S): Femcare, Gyne-Lotrimin, Mycelex

USES: This medication is used to treat vaginal yeast infections. Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

HOW TO USE: Read the Patient Information Leaflet available with this product. Consult your doctor or pharmacist if you have any questions.

If you are pregnant, follow your doctor's instructions on how to use the applicator to insert this medication.

Use the medication once daily, usually at bedtime or as directed by your doctor. Wash your hands before using the medication. If using the cream, use the disposable applicator. Follow the package instructions on how to fill the disposable applicator with the cream. Lie on your back with your knees toward your chest. Insert one applicator full of cream into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator all the way down to apply the cream. If you have itching/burning around the outside of the vagina (vulva), apply some cream to that area as well.

If using the vaginal tablet or combination pack, you may use either the applicator or your finger to insert the tablet. Unwrap the tablet before use. Follow the package instructions on how to fill the applicator with a vaginal tablet. Lie on your back with your knees toward your chest. Insert one applicator with a tablet into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator all the way down to release the tablet. If you have itching/burning around the outside of the vagina (vulva), apply the cream to that area. After use, throw away the applicator and wash your hands.

Continue to use this medication every day for the full time prescribed, even if symptoms disappear after a few days or if your menstrual period starts. Stopping the medication too soon may allow the yeast infection to return. Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication.

Inform your doctor if your condition persists or returns 1 week after completing the treatment.

SIDE EFFECTS: Burning/itching/pain in the vagina/urinary opening or lower abdominal cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clotrimazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (e.g., butoconazole, fluconazole); or to mineral oil; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems, 4 or more vaginal yeast infections per year.

Tell your doctor immediately if you have fever, chills, flu-like symptoms, or stomach/abdominal pain. This may mean you have a more serious infection and need another treatment.

Ask your doctor whether you can have sexual intercourse while using this product. Avoid using a diaphragm, cervical cap, or latex condoms for birth control while using this product and for 3 days after treatment is finished. Some ingredients in these medicines may damage these products, possibly causing them to break. Use other forms of birth control such as polyurethane condoms.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral antibiotics, corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This product may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., KOH smear, culture) may be performed periodically to monitor your progress. Consult your doctor for more details.

Dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily. This may help to prevent the growth of yeast.

If your sexual partner experiences symptoms, they should contact their doctor immediately.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the cream at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.