Miconazole Nitrate Vaginal Cream, USP
Drug Labeling and Warnings
Drug Details [pdf]
MICONAZOLE 7- miconazole nitrate cream
Fred's Inc.
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Miconazole Nitrate Vaginal Cream, USP
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
-
adults and children 12 years of age and over:
- applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash 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, irritated 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
- to open tube use cap to puncture seal
- 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°F).
Inactive ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Principal display panel
fred’s Pharmacy
NDC: 55315-730-63
7 DAY VAGINAL CREAM
1 TUBE WITH 1 REUSABLE APPLICATOR
Miconazole 7
MICONAZOLE NITRATE VAGINAL CREAM, USP 2%
(MICONAZOLE NITRATE 100 MG PER APPLICATOR)
VAGINAL ANTIFUNGAL
Cures Most Vaginal Yeast Infections
Relieves Associated External Itching & Irritation
NET WT 1.59 OZ (45g) TUBE
Compare To Active Ingredient in *Monistat® 7 Vaginal Cream
| MICONAZOLE 7
miconazole nitrate cream |
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| Labeler - Fred's Inc. (005866116) |
| Registrant - Teva Pharmaceuticals USA, Inc. (001627975) |
Revised: 4/2019
Document Id: fb17a51b-b197-4f56-9b5b-d2239dcc6212
Set id: d9e3f2e7-2848-4d95-b2ae-7f863e7b1a07
Version: 9
Effective Time: 20190418
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