MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT- miconazole nitrate kit
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit by
Drug Labeling and Warnings
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc., Cosette Pharmaceuticals NC Laboratories, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- Active ingredients
- Purpose
- Uses
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Warnings
For vaginal use only
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for
your symptoms, including diabetes or a weakened immune system. - been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are
taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.
When using this product
- do 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).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
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Directions
before using this product read the enclosed consumer information leaflet for complete directions and information
adults and children 12 years of age and over:
suppositories:insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
external cream: use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Apply to itchy,
irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.children under 12 years of age: ask a doctor
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Other information
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°)
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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EDUCATIONAL BROCHURE
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg (mye kon’ a zole nye’ trate), and
MICONAZOLE NITRATE VAGINAL CREAM, USP 2% (mye kon’ a zole nye’ trate)
VAGINAL ANTIFUNGAL
Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation
Why should I use Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP?
Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP contains 3 suppositories 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP if this is the first time you have vaginal discharge, itching, burning and discomfort. See your doctor or health professional firstto 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP 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-CDC-INF0 (1-800-232-4636) (English and Spanish), or 1-888-232-6348 (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:
vaginal itching
vaginal discharge that may be thick, white, and lumpy like cottage cheese
vaginal soreness, irritation, or burning
rash or redness on the skin outside of the vagina (vulva)
burning on urination
painful vaginal intercourse (sex)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 (GO) 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:hormonal changesoccurring a few days before the monthly period
use of antibiotics
use of some birth control pills
pregnancy
diabetes (“sugar” or “high blood sugar”)
clothing -wearing tight layers or moist clothing in the genital area
weakened immune system -some drugs (such as chemotherapy or steroids) and medical conditions can weaken the body’s normal abilityto 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 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP.
How can I prevent repeated vaginal yeast infections?
To lower your chances of getting another yeast infection:
Try 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 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.
Talk with your doctor about any drugs you are now taking.You are more likely to get a 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. A doctor may need to see you to make sure that you do not have other medical conditions such as diabetes or a weakened immune system.
Can I use Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP?
This drug should notbe used with other vaginal products.
Douches and tampons may remove some of the suppository from the vagina.
Spermicides may interfere with Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP.
Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).How can I get the best results when treating my infection?
Use 1 suppository at bedtime, even during your menstrual period for 3 nights in a row.
Use the tube of cream externally only while symptoms are present. If you have symptoms (such as itching and irritation) on the skin outside the vagina (vulva), apply the cream externally 2 times a day, up to a total of 7 days, as needed.
Dry the genital area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or damp clothes as soon as possible. A dry area is less likely to lead to the overgrowth of yeast.
Wear cotton underwear and loose-fitting clothes.
Wipe from front to back after a bowel movement or after urination.
Do not douche, because douching may wash the drug out of the vagina.
Do not use tampons, because they remove some of the drug from the vagina. Use deodorant-free sanitary napkins or pads as needed.
Do not use spermicides, as they may interfere with Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP.
Do not have vaginal intercourse while using Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP.
Do not scratch the skin outside the vagina. Scratching can cause more irritation and can spread the infection.
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 get a vaginal yeast infection. If you are taking any of these drugs do not stop taking them without first asking a doctor.
If you have any other medical questions or concerns about vaginal yeast infections, call your doctor.
What warnings should I know about when using Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP?
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.
lower abdominal, back 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 or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
been exposed to the human immunodeficiency virus (HIV) that causes AIDS.
Ask a doctor or pharmacist before useif you are taking the prescription blood thinning medicine, warfarin (coumadin), because bleeding
or bruising may occur.When using this product:
do 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).do not have vaginal intercourse
mild increase in vaginal burning, itching or irritation may occur
if you do not get complete relief ask a doctor before using another product.
How should I use Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP?
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 3 Applicators and 3 Suppositories:Begin treatment before going to
bed:1.Open pouch and remove contents (see picture). KEEP CONTENTS DRY BEFORE USE. OPEN POUCH JUST BEFORE USE.
2.Place the suppository firmly into the top (wider end) of the applicator so it will not fall out (see picture).
3.Hold the applicator containing the suppository by the opposite end from where the suppository is located.
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 picture), or while standing with your feet apart and knees bent.
5.With one hand holding the barrel, use the other hand to push the plunger all the way in to place the suppository as far back in the vagina as possible. Then remove both parts of the applicator from the vagina.
6.For disposable applicators: “Throw applicator away after use.” For reusable applicator: “Wash applicator after use”. Do not flush in toilet.
7.Lie down as soon as possible after inserting the suppository. This will reduce leakage.
8.Repeat steps 1-7 before bedtime for the next 2 days. You may want to use deodorant-free pads or pantyshields to protect your clothing during the time that you are using Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP. This is because the suppository can leak or you may get some discharge. Do not use tampons, douches, spermicides, condoms or diaphragmsuntil after you have completed the 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 (as shown).
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:
symptoms do not get better in 3 days
symptoms last more than 7 days
you get 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 Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP?
A mild increase in vaginal burning, itching, or irritation may occur when the applicator containing a suppository is inserted. Abdominal cramping has also been reported. Stop using Miconazole Nitrate Vaginal Suppositories, USP and Miconazole Nitrate Vaginal Cream, USP and consult your doctor if you have abdominal pain, headache, hives, skin rash, or if you have severe vaginal burning, itching, or irritation or swelling.
What should I do if I have questions about Miconazole Nitrate Vaginal Cream?
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 at 1-800-922-1038Monday-Friday 9AM-5PM EST.
Other Information:
TAMPER-EVIDENT UNIT - do not use if printed sealed pouches are open or incompletely sealed.
do not use if seal over tube opening has been punctured or is not visible.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
Active Ingredients:
Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2 % (external cream)
Inactive Ingredients:
suppository: hydrogenated vegetable oil
external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Manufactured by:
Cosette Pharmaceuticals NC Laboratories, LLC
Lincolnton, NC 28092
VC7770
Rev. 05/2024
8-0593GEN1
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Principal Display Panel
Compare to the active ingredient in Monistat® 3*
NDC 0713- 0593-77
3-Day Treatment
Miconazole Nitrate
Combination Pack
Miconazole Nitrate Vaginal Antifungal Cream, USP 2% and
Miconazole Nitrate Vaginal Suppositories, USP 200 mgVaginal Antifungal
- cures most vaginal yeast infections
- relieves associated external itching and irritation
Net Wt. 0.32 oz (9 g) tube
3 suppositories with
3 disposable applicators
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INGREDIENTS AND APPEARANCE
MICONAZOLE 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0713-0593 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0713-0593-77 1 in 1 CARTON; Type 0: Not a Combination Product 01/03/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 9 Part 2 1 TUBE 9 g Part 1 of 2 MICONAZOLE NITRATE
miconazole nitrate suppositoryProduct Information Item Code (Source) NDC: 0713-0595 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 200 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 Part 2 of 2 MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Item Code (Source) NDC: 0713-0594 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074926 01/03/2025 Labeler - Cosette Pharmaceuticals, Inc. (116918230) Establishment Name Address ID/FEI Business Operations Cosette Pharmaceuticals NC Laboratories, LLC 079419931 manufacture(0713-0593) , pack(0713-0593) , label(0713-0593) , analysis(0713-0593)
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