miconazole nitrate
Dosage Form: vaginal cream, vaginal suppositories
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal
DRUG FACTS
| Active ingredients | Purpose |
|---|---|
| Miconazole nitrate (200 mg in each suppository) | Vaginal antifungal |
| Miconazole nitrate 2% (external cream) | Vaginal antifungal |
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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.
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 away applicator 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
- do not use if printed suppository blister is torn, open or incompletely sealed
do not use if seal over tube opening has been punctured or embossed design
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
Inactive ingredients
suppository: hydrogenated vegetable oil base
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Questions? If you have any questions or comments, please call 1-877-666-4782
Visit our website @ www.monistat.com
PRINCIPAL DISPLAY PANEL
30014-018-03
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal uppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal
(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)
CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION
ORTHO
3 Vaginal Suppositories with Reusable
Applicator plus External Cream
Net Wt. 3 Suppositories
0.32 oz (9g) tube
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020670 | 12/10/2009 | |
| Labeler - McNeil-PPC, Inc. (801375143) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Draxis Specialty Pharmaceuticals Inc., Canada | 243604761 | Analysis, Manufacture | |
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