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Consumer Information 3-Day TreatmentCONSUMER INFORMATION LEAFLETMiconazole Nitrate Vaginal Cream (4%)VAGINAL ANTIFUNGALCures Most Vaginal Yeast InfectionsWhy should use this productThis product contains 4% miconazole nitrate cream in prefilled applicators that cures most vaginal yeast infections. Do not use this product if this is the first time you have vaginal discharge, itching, burning and discomfort. See your doctor or health professional first to find out the cause of your symptoms. If doctor has told you in the past that you had vaginal yeast infection and you have the same symptoms now (such as vaginal discharge, itching or burning), then this product may work for you.What is vaginal yeast infectionA vaginal yeast infection is 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 yeast infection on the skin outside of the vagina (vulva) at the same time that they have vaginal infection.Who can get vaginal yeast infectionYou can get 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 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 bodys 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 numbers are: 1-800-232-4636 (English/Spanish), or 1-888-232-6348 (hearing impaired, TTY).How can tell if have vaginal yeast infectionWhen you have vaginal yeast infection, you may have one or more of the following symptoms:ovaginal itchingovaginal discharge that may be thick, white, and lumpy like cottage cheeseovaginal soreness, irritation, or burningorash or redness on the skin outside the vagina (vulva)oburning on urinationopainful vaginal intercourse (sex)Note: Vaginal yeast infections do NOT cause fever, chills, lower abdominal, back or shoulder pain, foul-smelling vaginal discharge, or missed period. These may be signs of sexually transmitted disease (STD) or tubal pregnancy. If you have these symptoms, call your doctor right away.What are other causes of vaginal dischargeIt is normal to have 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 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 Hotline at 1-800-232-4636.Although many of the infections mentioned above can cause symptoms similar to vaginal yeast infection (vaginal discharge, irritation and itching), their diagnosis must be made by 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 new sex partner, you should also ask doctor before use to make sure you do not have an STD.Why do women get repeated vaginal yeast infectionsWomen 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:ohormonal changes occurring few days before the monthly periodouse of antibioticsouse of some birth control pillsopregnancyodiabetes (sugar or high blood sugar)oclothing wearing tight layers or moist clothing in the genital areaoweakened immune system some drugs (such as chemotherapy or steroids) and medical conditions can weaken the bodys 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). Infection with HIV causes the person to be more likely to get infections, including vaginal yeast infections.If you get vaginal yeast infections often (such as once month or in months), you should talk to doctor.Are vaginal yeast infections sexually transmittedVaginal yeast infections are usually not spread by having intercourse (sex). However, if your partner has rash, itching or discomfort in his genital area, he should contact doctor to find out the cause of his symptoms and tell the doctor that you are treating your vaginal yeast infection with this product.How can prevent repeated vaginal yeast infectionsTo lower your chances of getting another yeast infection:oTry to keep the genital area cool and dry. Yeast grow well in warm, moist areas. The following suggestions may be helpful:(1) Wear cotton underwear and loose-fitting clothes.(2) Change out of damp clothes or wet bathing suit as soon as possible.(3) If you use minipads when you are not having menstrual period, change the minipads often.oTalk with your doctor about any drugs you are now taking. You are more likely to get vaginal yeast infection if you are taking certain drugs such as antibiotics, steroids, or birth control pills. Do not stop taking these drugs without first asking your doctor. doctor may need to see you to make sure that you do not have other medical conditions such as diabetes or weakened immune system.Can use this product during my menstrual periodYes, 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 this product 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 use other vaginal products with this productThis drug should not be used with other vaginal products.oDouches and tampons may remove some of the cream from the vagina.oSpermicides may interfere with this product.oCondoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).How can get the best results when treating my infectionoUse prefilled applicator of vaginal cream at bedtime, even during your menstrual period for nights in row.oDry the genital area thoroughly after shower, bath or swim. Change out of wet bathing suit or damp clothes as soon as possible. dry area is less likely to lead to the overgrowth of yeast.oWear cotton underwear and loose-fitting clothes.oWipe from front to back after bowel movement or after urination.oDo not douche, because douching may wash the drug out of the vagina.oDo not use tampons, because they remove some of the drug from the vagina. Use deodorant-free sanitary napkins or pads as needed.oDo not use spermicides, as they may interfere with this product.oDo not have vaginal intercourse while using this product.oDo not scratch the skin outside the vagina. Scratching can cause more irritation and can spread the infection.oTell 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 get vaginal yeast infection. If you are taking any of these drugs do not stop taking them without first asking doctor. oIf you have any other medical questions or concerns about vaginal yeast infections, call your doctor.What warnings should know about when using this productFor vaginal use only.Do not use if you have never had vaginal yeast infection diagnosed by doctor.Ask doctor before use if you have:ovaginal itching and discomfort for the first time. You may need different treatment.olower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You could have more serious condition.ovaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system.obeen exposed to the human immunodeficiency virus (HIV) that causes AIDS.Ask doctor or pharmacist before use if you are taking the prescription blood thinning medicine, warfarin (coumadin), because bleeding or bruising may occur.When using this product:odo 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).odo not have vaginal intercourseomild increase in vaginal burning, itching or irritation may occuroif you do not get complete relief ask doctor before using another productHow Should Use This ProductThis product is for adults and children 12 years of age and over. For children under 12 years, ask doctor.Directions for using the Applicator containing the Vaginal Cream:Begin treatment before going to bed:1 Remove the prefilled applicator from the wrapper.2 Unscrew and remove violet cap from prefilled applicator.3 Insert plunger into prefilled applicator by placing small end of plunger into the ribbed end of the applicator.4 Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while lying on your back with your knees bent (as shown in the picture) or while standing with your feet apart and your knees bent.5 With one hand holding the barrel, use the other hand to push the plunger all the way in to place the cream as far back in the vagina as possible. Then remove both parts of the applicator from the vagina.6 Throw the applicator away after use. Do not flush in toilet.7 Lie down as soon as possible after inserting the cream. This will reduce leakage.8 Repeat steps through before going to bed for the next days.You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that you are using this product. This is because the cream can leak or you may get some discharge. Do not use tampons, douches, spermicides, condoms or diaphragms until after you have completed treatment and your symptoms are gone.Stop use and ask your doctor if:osymptoms do not get better in daysosymptoms last more than daysoyou get 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 more serious condition or an allergic reaction.If pregnant or breast-feeding, ask health professional before use.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).What side effects may occur with this productA 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 this product 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 do if have questions about this productIf you have questions of medical nature, please contact your pharmacist, doctor or health care professional. If you have any other questions or need more information on this product, call our toll-free number 1-800-719-9260. Other Information:oTAMPER-EVIDENT UNIT do not use if printed applicator wrapper is torn, open or incompletely sealed.ostore at 20-25C (68-77F)Active Ingredient: miconazole nitrate 4% (200 mg per applicator)Inactive Ingredients: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.Distributed ByPerrigo(R)Allegan, MI 4901010/16: 07000 00 J1. ovaginal itching. ovaginal discharge that may be thick, white, and lumpy like cottage cheese. ovaginal soreness, irritation, or burning. orash or redness on the skin outside the vagina (vulva). oburning on urination. opainful vaginal intercourse (sex). ohormonal changes occurring few days before the monthly period. ouse of antibiotics. ouse of some birth control pills. opregnancy. odiabetes (sugar or high blood sugar). oclothing wearing tight layers or moist clothing in the genital area. oweakened immune system some drugs (such as chemotherapy or steroids) and medical conditions can weaken the bodys 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). Infection with HIV causes the person to be more likely to get infections, including vaginal yeast infections.. oTry to keep the genital area cool and dry. Yeast grow well in warm, moist areas. The following suggestions may be helpful:. oTalk with your doctor about any drugs you are now taking. You are more likely to get vaginal yeast infection if you are taking certain drugs such as antibiotics, steroids, or birth control pills. Do not stop taking these drugs without first asking your doctor. doctor may need to see you to make sure that you do not have other medical conditions such as diabetes or weakened immune system.. oDouches and tampons may remove some of the cream from the vagina.. oSpermicides may interfere with this product.. oCondoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).. oUse prefilled applicator of vaginal cream at bedtime, even during your menstrual period for nights in row.. oDry the genital area thoroughly after shower, bath or swim. Change out of wet bathing suit or damp clothes as soon as possible. dry area is less likely to lead to the overgrowth of yeast.. oWear cotton underwear and loose-fitting clothes.. oWipe from front to back after bowel movement or after urination.. oDo not douche, because douching may wash the drug out of the vagina.. oDo not use tampons, because they remove some of the drug from the vagina. Use deodorant-free sanitary napkins or pads as needed.. oDo not use spermicides, as they may interfere with this product.. oDo not have vaginal intercourse while using this product.. oDo not scratch the skin outside the vagina. Scratching can cause more irritation and can spread the infection.. oTell 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 get vaginal yeast infection. If you are taking any of these drugs do not stop taking them without first asking doctor. oIf you have any other medical questions or concerns about vaginal yeast infections, call your doctor.. ovaginal itching and discomfort for the first time. You may need different treatment.. olower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You could have more serious condition.. ovaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system.. obeen exposed to the human immunodeficiency virus (HIV) that causes AIDS.. odo 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).. odo not have vaginal intercourse. omild increase in vaginal burning, itching or irritation may occur. oif you do not get complete relief ask doctor before using another product. osymptoms do not get better in days. osymptoms last more than days. oyou get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.. oTAMPER-EVIDENT UNIT do not use if printed applicator wrapper is torn, open or incompletely sealed.. ostore at 20-25C (68-77F). image 3. image 4.