MICONAZOLE NITRATE- miconazole nitrate cream
Cosette Pharmaceuticals, Inc.
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Miconazole Nitrate Vaginal Cream 2 %
7 Day Vaginal Cream
ACTIVE INGREDIENT
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
USES
• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat 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 medication warfarin, because bleeding or bruising may occur.
When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
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
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION
• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
• applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
• external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated
skin outside the vagina. Use 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 cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.
| MICONAZOLE NITRATE
miconazole nitrate cream |
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| Labeler - Cosette Pharmaceuticals, Inc. (116918230) |
| Registrant - Cosette Pharmaceuticals, Inc. (116918230) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cosette Pharmaceuticals, Inc. | 116918230 | analysis(0713-0252) , manufacture(0713-0252) , label(0713-0252) , pack(0713-0252) | |