Vagistat 3
Miconazole nitrate · Kit
Active ingredient
Active ingredients Miconazole nitrate (200 mg in each suppository) Miconazole nitrate 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
• if you do not get complete relief ask a doctor before using another product 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 right away (1-800-222-1222).
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
• if you do not get complete relief ask a doctor before using another product
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 right away (1-800-222-1222).
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: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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 printed suppository wrapper is torn, open or incompletely sealed
• do not use if seal over tube opening has been punctured
• do not purchase if carton is open
• store at 20 ° -25 ° C (68 ° -77 ° F)
Inactive ingredients
Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, glyceryl stearate, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
Questions?
Questions or comments? 1-800-719-9260
Label text from the FDA structured product label by Combe Incorporated (revised Nov 1, 2025). Long sections are shortened; the complete label is on DailyMed.
Vagistat 3 NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 11509-0081 | Kit | Combe Incorporated | ANDA |
Frequently asked questions
What is Vagistat 3 used for?
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Who makes Vagistat 3?
Vagistat 3 is listed by 1 labeler in the FDA NDC directory, including Combe Incorporated.