Miconazole nitrate 2% (100 mg in each applicatorful)
Purpose
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:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use.
- use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritate skin outside the vagina (vulva). 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 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
- 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
PRINCIPAL DISPLAY PANEL - 45g Tube Carton
NDC 30014-024-15
MONISTAT® 7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg per application)
CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION
ORTHO
7 Day Vaginal Cream
with Disposable Applicators
Net Wt.
1.59 oz. (45g) tube
| MONISTAT 7 7-DAY DISPOSABLE APPLICATORS miconazole nitrate cream | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017450 | 04/15/2010 | |
| Labeler - McNeil-PPC, Inc. (801375143) |
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Compare Monistat 7 Cream with other medications
- Cutaneous Candidiasis
- Oral Thrush
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- Tinea Versicolor
- Vaginal Yeast Infection
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