MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit
Miconazole nitrate · Kit
Active ingredient
Active ingredients Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)
Purpose
Purpose Vaginal antifungal
Uses
Uses
• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection
Warnings
Warnings 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 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 Stop use and ask a 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 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 (1-800-222-1222) right away.
Do not use
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a doctor before use
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
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
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
Stop use and ask a doctor
Stop use and ask a 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
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
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
Other information
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
Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Questions?
Questions? Call 1-800-922-1038 Monday-Friday 9AM-5PM EST
Label text from the FDA structured product label by Cosette Pharmaceuticals, Inc. (revised Jan 6, 2025). Long sections are shortened; the complete label is on DailyMed.
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0713-0593 | Kit | Cosette Pharmaceuticals, Inc. | ANDA |
Frequently asked questions
What is MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit used for?
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Who makes MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit?
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit is listed by 1 labeler in the FDA NDC directory, including Cosette Pharmaceuticals, Inc..