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`

`

`- Do not use spermicides. as they may interfere with MONISTATg 7
`Vaginal Cream Combination Pack.
`' Do not have vaginal intercourse while using MONIS'I'ATw T Vaginal
`Cream Combination Pack.
`- Do not scratch the skin outside the vagina. Scratching can cause
`more irritation and can spread the infection.
`0 Tell your doctor about any drugs you are now taking. Certain drugs
`such as antibiotics. steroids, and birth control pills. may make it more
`likely for you to gel a vaginal yeast infection. It you are taking any of
`these drugs do not stop taking them without first asking a doctor.
`I If you have any other medical questions or concerns about vaginal
`yeast infections. call your doctor.
`What warnings should I know about when using MONISTAT' 'I'
`Vaginal Cream Combination Pack?
`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. You may need
`a different treatment.
`I lower abdominal. book or shoulder pain. fever. chills. nausea.
`vomiting, or foul-smelling vaginal discharge. You could have a
`more serious condition.
`- vaginal yeast infections often {such as once a month era in 5
`months]. You could be pregnant or have a serious underlying
`medical cause for your symptoms. inciudlng diabetes or a
`weakened immune system.
`I been exposed to the human immunodeficiency virus (HIV; that
`causes AIDS.
`Ask a doctor or pharmacist before use it you are taking the
`prescription blood thinning medicine, warlarin [coumadin).
`because bleeding or bruising may occur.
`When using this product:
`I do not use tampons, douches. spennicldes. or other vaginal products.
`Condoms and diaphragms may be damaged and fail to prevent
`pregnancy or sexually transmitted diseases (STDs).
`I do not have vaginal
`intercourse
`I mild increase in vaginal
`burning. itching or irritation
`may occur
`it you do not get complete
`relief ask a doctor before
`using another product
`
`I
`
`OSEIUZ
`
`andof plunger into the gray little at end-of the applicator.
`PLUNGER
`BARREL
`
` -,.-,
`
`
`
`4 Gently Insert the applicatorinto the vagina as for as it
`will go comfortably. This can be done while lying on ydur
`back with your knees bent (as shownIn the picture) or
`while standing with your feetp art and your knees bent.
`
`
`
`5 With onehand holding the barrel, use the other
`handto push the plunger- allithe way in to place the
`cre'a'rn asfor backIn the vaginaas possible. Then
`remove both parts of the applicator from the vagina-
`6 Throw the applicator away after-.uso Do not flush
`in toilet.
`F
`7 Us down as soon as possible after inserting the
`cream. This will reduce lepak'age.
`
`Repeat steps 1 through 7 beforegolrig to bed for
`the next 6 days.
`
`You may want to use doodoi‘antn‘roo pads or pantyshields
`to protect your clothing during-the. time that you are using
`MONIS‘IIGIT'7 Vaginal Cream Combination Pack. This is
`because the cream can leak or you may get some
`disoharge. Do not use tampons. douches. spermicides.
`condoms or diaphragme with after you have completed
`neatrnont and yoursymptoms are gone.
`
`Stop use and ask your doctor if:
`. symptoms do not get better in 3 days
`I symptoms last more than 7 days
`I you got a rash or hives. abdominal pain. fever. chills. nausea.
`vomiting. or foul-smelling vaginal discharge.
`These may be signs that this product is not working, or you may have
`a more serious condition or an allergic reaction.
`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.
`What side effects may occur with MONISTAT' 1 Vaginal Cream
`Combination Pack?
`
`A mildIncrease in vaginal burning. itching, or irritation may occur
`when the MONISTAT iVaginal CreamIs inserted. Abdominal
`cramping has also been reported.
`Stop using MONlSTAT'”? Vaginal Cream Combination Pack and
`consult your doctor it you have abdominal pain. hives. skin rash. or it
`you have severe vaginal burning. itching. or irritation or swetllng.
`What should I do It I have questions about MONISTAT' 7 Vaginal
`Cream Combination Pack?
`Questions of a medical nature should be taken up with your doctor.
`you have any other questions or need more information on this product,
`call our toll-free number. Call between 8:00 Alvl and 5:00 PM Eastern time
`Monday through Friday. A health care specialist will gladly answer your
`questions. Our toll-free number is t -877-MONISIIAT (t hit—6564782).
`Other Information:
`- TAMPEH-EVIDENT UNIT - do not use if printed applicator wrapper
`is torn. open or incompletely sealed.
`. do not use il tube seal has been punctured or embossed design U
`symbol is not visible.
`I store at 20” - 253 C (58” - 7’?“ Fl
`Active Ingredients
`MONISTAT" T Pretilled AppIIcators: miconazole nitrate 2% [I 00 mg
`per applicator)
`lvlthISi’Ittifi Extema! Vulvar Cream: mIoonazole nitrate 2%
`Inactive Ingredients
`Benzoic acid. cetyi alcohol. Isopropyn myristate. polysorbate 60.
`potassium hydroxide. propylene glycol, purified water. stearyl alcohol.
`
`Distributed by:
`McNEIL—P?C. Inc.
`Skilfman. NJ 0855Bn94I8
`MADE IN CANADA
`© McNEIL—PPC. Inc. 2005
`
`

`

`Consumer Information Leaflet
`
`Miconazola Nitrate Vaginal Cream (2%) and Miconazale Nitrate Vaginal Crream (2/0)
`
`MONISTAT
`
`COMBINATION PACK
`
`7
`
`VAGINAL ANTIFUNGAL
`
`201350
`
`IIII
`
`IIIIII
`
`Why should I use MONISTAT' 7 Vaginal Cream Combination Pack?
`MONISTAT“ 7 Vaginal Cream Combination Pack contains vaginal
`cream that cures most vaginal yeast infections, plus an external
`cream that can be used for relief of itching and irritation on the skin
`outside the vagina (vulva) due to a yeast infection. Do not use
`MONlSTAT’ 7 Vaginal Cream Combination Pack if this is the first
`time you have vaginal discharge. itching. homing and discomfort.
`See your doctor or health professional Let in 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 vagina! discharge. itching or burning), then MDNISTAT" 7
`Vaginal Cream Combination Pack may Work for you.
`
`A vaginal yeast Infection is a common condition caused by an
`overgrowth of yeast (Candida) that may normally live in the vagina.
`Yourdoctor 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.
`
`Cures Most Vaginal Yeast Infections
`Relieves External Vulvar Itching and Irritation Associated With a Yeast Infection
`Note: Vaginal yeast infections do NOT cause fever. chillsI
`It you get vaginal yeast infections often (such as once a month or
`lower abdominal. back or shoulder pain. foul-smelling vaginal
`3 in 6 months), you should talk to a doctor.
`discharge. or a missed period. These may be signs of a sexually
`Are vaginal yeast infections sexually transmitted?
`transmitted disease (STD) or a tubal pregnancy. If you have
`Vaginal yeast infections are usually not spread by having
`these symptoms, call your doctor right away.
`intercourse (sex). However, if your partner has a rash. itching or
`What are other causes of a vaginal discharge?
`discomfort'rn his genital area. he should contact a doctor to find out
`the cause of his symptoms and tell the doctor that you are treating
`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
`your vaginal yeast infection with MONISTAT” T Vaginal Cream
`Combination Pack.
`white and does not cause itching. pain or a foul odor.
`The most common cause of an abnormal vaginal discharge is an
`How can I prevent repeated vaginal yeast Infections?
`infection. These infections include bacterial vaginosis (EV),
`To lower your chances of getting another yeast infection:
`trlchomoniasis Uriah), gonorrhea (GD) and/or chlamydia. All of these
`. Try to keep the genital area cool and dry. Yeast grow well In
`may be transmitted sexually and are called sexually transmitted
`warm, moist areas. The following suggestions may be helpful:
`diseases (STDs). If you have more questions about sexually
`(1) Wear cotton underwear and loose—fitting clothes.
`transmitted diseases (STDs) call the CDC STD Hotline at
`Patient-8922.
`(2) Change out of damp clothes or a wet bathing suit as soon as possible.
`Although many of the infections mentioned above can cause
`(3) If you use minipads when you are not having a menstrual period.
`symptoms similar to a vaginal yeast infection (vaginat discharge.
`change the minipads often.
`irritation and itching). their diagnosis must be made by a doctor so
`- Talk with your doctor about any drugs you are now taking.
`that proper treatment can be given.
`You are more likely to get a vaginal yeast infection it you are taking
`If these infections are not property treated or if proper treatment I5
`certain drugs such as antibiotics, steroids. or birth control pills.
`delayed. serious problems, such as pelvic inflammatory disease (PID)
`Do not stop taking these drugs without first asking your doctor. A
`may result. which may prevent you from having children in the future.
`doctor may need to see you to make sure that you do not have other
`If you are pregnant and do not get the proper treatment, the infection
`medical conditions such as diabetes or a weakened immune system.
`may be passed to your baby before or during detivery and may
`Can I use MlIJNISTitT'n ‘i Vaginal Cream Combination Pack during
`cause your baby to have permanent damage.
`If you have multiple
`my menstrual period?
`sex partners or a new sex partner. you should also ask a doctor
`Yes. this product can be used during your menstrual period.
`before use to make sure you do not have an STD.
`In fact. many WOmen get vaginal yeast infections just before their
`Why do women get repeated vaginal yeast infections?
`period because of hormonal changes. Using MONISTAT’ 7 Vaginal
`Women may get repeated vaginal yeast infections that may not
`Cream Combination Pack during your period will not affect how well
`clear up easily with proper treatment. Listed below are some of the
`this product works. If you have started treatment and your period
`
`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 vinrs 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
`
`
`
`MANUFACTURER CUUPUN
`I2i3ti'201t
`
`
`$2.00!
`
`Save $2.00 from
`the Makers of
`MONI5TA T®:
`
`SOOTHING CARE®
`itch Relief Cream
`
`SOOTHING CARE®
`Chafing Relief
`POWDER-GEL TM
`
`COOL WiPES®
`Feminine Wipes
`SOOTHE &
`RELIEVE PACKTM
`
`it
` ;.i-ntunaCurt"
`
`SODTHING CAREg
`Itch Relief Cream
`Relieves Itching and Inflation
`
`
`
`SOOTHING CARE"
`Chafing Relief
`POWDER-GEL“
`fielieves and Prevents Chafing
`
`
`
`'
`'
`'
`COOLWIPES®
`Feminine Wipes
`Cleans and Cools
`
`III
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`
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`
`
`
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`
`
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`
`

`

` MONISTAT‘”
`
`
`EXTERNAL VULVAR CREAM
`Micona zole Nitrate Cream (2%]
`
`
`EXTERNAL USE ONLY
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