Smart sense 3 day treatmentvaginal antifungal kit
Miconazole nitrate 4% (200 mg in each applicator)
Miconazole nitrate 2% (external cream)
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 if you are
taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur
When using this product
Stop use and ask a doctor if
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.
Questions or comments?
CONSUMER INFORMATION LEAFLET
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation
Why should I use this product?
This product contains 3 cream prefilled applicators that cure 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 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 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 this product 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 numbers are: 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (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 this product.
How can I prevent repeated vaginal yeast infections?
To lower your chances of getting another yeast infection:
(1) Wear cotton underwear and loose-fitting clothes.
(2) Change out of damp clothes or a wet bathing suit as soon as possible.
(3) If you use minipads when you are not having a menstrual period, change the minipads often.
Can I use this product 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 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 I use other vaginal products with this product?
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 this product?
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 if you aretaking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur.
When using this product:
How Should I Use This Product?
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 Applicators containing Vaginal Cream:
Begin treatment before going to bed:
1Remove the prefilled applicator from the wrapper.
2Unscrew and remove violet cap from prefilled applicator.
3Insert plunger into prefilled applicator by placing small end of plunger into the ribbed end of the applicator.
4Gently 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.
5With one hand holding the barrel use the other hand to push the plunger as far into the barrel as it will go. Remove both parts of the applicator from the vagina.
6Throw the applicator away after use. Do not flush it down the toilet.
7Lie down as soon as possible after inserting the cream. This will reduce leakage.
8Repeat steps 1 through 7 before going to bed for the next 2 days.
You may want to use deodorant-free minipads 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, or spermicidesuntil after you have completed treatment and your symptoms are gone.
Directions for using the External Vulvar Cream
Use the cream twice daily, for up to 7 days as needed.
1.Open the tube by unscrewing the cap. The first time the tube is opened, press the sharp point of the cap into the sealed end of the tube. Push down firmly until the seal is open.
2.Squeeze a small amount of cream onto your fingertip.
3.Apply the cream onto the skin outside the vagina (vulva) that itches and is irritated.
4.Screw the cap back on the tube.
5.Repeat steps 2-4 each morning and at bedtime for up to 7 days, as needed.
Stop use and ask your doctor if:
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 this product?
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 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 I do if I have questions about this product?
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 our toll-free number 1-800-719-9260
Prefilled Applicators: miconazole nitrate 4% (200 mg per applicator)
External Vulvar Cream: miconazole nitrate 2%
Prefilled Applicators: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol.
External Vulvar Cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water.
:98200 00 J2
Ingredients and appearance - Product information
Smart sense 3 day treatmentvaginal antifungal kit- Miconazole nitrate
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 49738-982|
|Route of Administration||Vaginal|
|Color||WHITE (to off white, viscous)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
Labeler - Kmart Corporation( 008965873)
Principal display panel
Compare to the active ingredients of Monistat® 3 Combination Pack
3 DAY TREATMENT
MICONAZOLE NITRATE VAGINAL CREAM (4%) AND MICONAZOLE NITRATE CREAM (2%)
(MICONAZOLE NITRATE 200mg PER APPLICATOR PLUS 2% EXTERNAL VULVAR CREAM)
Cures Most Vaginal Yeast Infections
Relieves Associated External Itching And Irritation
3 PREFILLED APPLICATORS plus EXTERNAL VULVAR CREAM