ACTIVE INGREDIENT

(in each applicatorful)

Clotrimazole 50 mg (1%)

PURPOSES

Vaginal antifungal/external vulvar antifungal

USES

• treats vaginal yeast (candida) infections
• relieves external vulvar itching and irritation associated with a yeast infection

WARNINGS

For vaginal or external vulvar use only

DO NOT USE

• if you have abdominal pain, fever or a foul-smelling vaginal discharge. Contact your doctor immediately.
• in children less than 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

• vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.
• symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection with HIV – the virus that causes AIDS). Please read enclosed educational pamphlet.

WHEN USING THIS PRODUCT

Do not use tampons

STOP USE AND ASK A DOCTOR IF

Symptoms do not get better in 3 days or infection isn’t gone in 7 days. You may have a condition other than a yeast infection.

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 pamphlet
• fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Wash applicator after each use.
• 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.

Other Information

• store at room temperature between 2( and 30(C (36( to 86(F)
• see end flaps of carton and tube for lot number and expiration date
• safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product

INACTIVE INGREDIENTS

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

QUESTIONS?

1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunmark®

COMPARE TO GYNE-LOTRIMIN® ACTIVE INGREDIENT*

NDC 49348-793-76

clotrimazole

Vaginal Cream USP 1%

Vaginal Antifungal

Cures most vaginal yeast infections

Relieves associated external vulvar itching and irritation

EDUCATIONAL PAMPHLET ENCLOSED

VAGINAL CREAM AND ONE PLASTIC APPLICATOR (7-DAY THERAPY)

ONE 1.5 OZ (45 g) TUBE

1 REUSABLE APPLICATOR CARTON LABEL

EDUCATIONAL PAMPHLET

READ THIS BEFORE USING

Clotrimazole Vaginal Cream USP 1%

VAGINAL ANTIFUNGAL

FOR THE TREATMENT OF VAGINAL YEAST (CANDIDA) INFECTION AND THE RELIEF OF ASSOCIATED EXTERNAL VULVAR ITCHING AND IRRITATION

1. 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.

2. 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.

3. HOW TO USE WARNING: DO NOT TAKE BY MOUTH OR USE IN THE EYES.

   Directions:

   Fill the applicator with the cream and then insert one applicatorful of cream into the vagina every day, preferably at bedtime. Repeat this procedure 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.

   Applicator:

   

   To load the applicator:

   

   Remove cap from tube of cream. Turn the cap upside down and place the cap on the end of the tube. Push down firmly until the seal is broken. 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. Replace cap after each use.

   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.

   Care of the applicator:

   

   After use, pull the plunger all the way out of the barrel. Wash both parts of the applicator in warm (not boiling), soapy water. Rinse thoroughly and dry. To reassemble, gently push the plunger back into the barrel as far as it will go. 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.

   CLOTRIMAZOLE VAGINAL CREAM may reduce the effectiveness of some methods of birth control. Condoms, diaphragms, or vaginal spermicides may be so affected.

4. ARE THERE REASONS YOU GET YEAST INFECTIONS AND VULVAR IRRITATION?

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 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.

Can yeast be transmitted sexually?

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.

WARNINGS:

• 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 the reach of children. This product is not to be used in children less than 12 years of age.

IF YOU HAVE A QUESTION If you have any questions or need more information on this product, call our toll-free number. Questions of medical nature should be taken up with your doctor. Call between 9:00 am and 4:00 pm Eastern Time, Monday through Friday. Our toll-free number is 1-800-432-8534 (select option #2).

ACTIVE INGREDIENT: Clotrimazole 1%.

INACTIVE INGREDIENTS: Benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, and sorbitan monostearate.

See carton and tube crimp for lot number and expiration date. Store at room temperature between 2º-30ºC (36º-86ºF).

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 0220-63

Rev. 8/08

VC3339