Miconazole Nitrate
Drug Labeling and Warnings
Drug Details [pdf]
MICONAZOLE NITRATE- miconazole nitrate cream
Preferred Pharmaceuticals Inc.
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Miconazole Nitrate
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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
- if you do not get complete relief ask a doctor before using another product.
Directions
- before using this product read the enclosed consumer information leaflet for complete directions and information
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adults and children 12 years of age and over:
- applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
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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, irritated skin outside the vagina (vulva).
Use 2 times daily for up to 7 days as needed.
- children under 12 years: ask a doctor
Other information
- do not purchase if carton is opened
- do not use if seal over tube opening has been punctured or is not visible
To open: unscrew cap, use pointed end on cap to puncture seal
To close: screw cap back onto the tube
- store at 20°-25°C (68°-77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredients
Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative
Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
Relabeled By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL - 45 g 1 Reusable Applicator Carton
Cures Most Vaginal Yeast Infections
and Relieves Associated External Itching and Irritation
NDC: 68788-8989-4
7 Day Treatment
7 Day Vaginal Cream
Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)
One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator
Educational Brochure Enclosed
| MICONAZOLE NITRATE
miconazole nitrate cream |
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| Labeler - Preferred Pharmaceuticals Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 791119022 | RELABEL(68788-8985) | |