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Miconazole Nitrate by G&W Laboratories, Inc.
Dosage form: cream
Ingredients: Miconazole Nitrate 20mg in 1g
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0252
7 Day Vaginal Cream
Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)
Vaginal antifungal
• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat vaginal yeast infection
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
ask a health professional before use.
If swallowed, get medical help or contact a Poison Control Center right away.
• 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
• 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.
benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water
1-800-922-1038
| MICONAZOLE NITRATE
miconazole nitrate cream |
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| Labeler - G&W Laboratories, Inc. (001271188) |
| Registrant - G&W Laboratories, Inc. (001271188) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| G&W Laboratories, Inc. | 001271188 | MANUFACTURE | |
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.



