Miconazole Nitrate Vaginal Cream
Drug Labeling and Warnings
Drug Details [pdf]
MICONAZOLE 7- miconazole nitrate cream
Preferred Pharmaceuticals, Inc.
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Miconazole Nitrate Vaginal Cream
ACTIVE INGREDIENT
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
USES
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
ASK A DOCTOR BEFORE USE IF YOU HAVE
- vaginal itching and discomfort for the first time
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
- lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
Taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur
WHEN USING THIS PRODUCT
- do not use tampons, douches, spermicides or other vaginal products
- do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse (sex)
- mild increase in vaginal burning or irritation may occur
STOP USE AND ASK A DOCTOR IF
- symptoms do not get better after 3 days
- symptoms last more than 7 days
- you get a rash, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact the Poison Control Center right away.
DIRECTIONS
- before using this product read the enclosed brochure for complete instructions
- adults and children 12 years of age and over:
- applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
- external cream: squeeze a small amount of cream onto your fingertip. Gently 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: ask a doctor
-
Other Information
do not use if seal over tube opening has been punctured or cannot be seen
store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.
| MICONAZOLE 7
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(68788-9772) | |
Revised: 10/2019
Document Id: 1c528291-c0da-4050-a7d8-02c0863ecec8
Set id: f9f553cd-84b9-40ab-9756-e80670faf8c9
Version: 6
Effective Time: 20191030