FDA Label for Miconazole Nitrate
View Indications, Usage & Precautions
Miconazole Nitrate Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient
Miconazole Nitrate USP 2% (100 mg per applicator)
Purpose
Vaginal Antifungal
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only.
Otc - Do Not Use
Do not use if you have never had a vaginal yeast infection diagnosed by a doctor
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
Otc - When Using
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.
Otc - Stop Use
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 or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 one 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: 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
- store at 20°-25°C (68°-77°F)
- see carton or tube crimp for lot number and expiration date
To open: unscrew cap, use pointed end on cap to puncture seal
To close: screw cap back onto the tube
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
Questions?
Call 1-866-923-4914
How Supplied
Product: 50090-4356
NDC: 50090-4356-0 45 g in a TUBE, WITH APPLICATOR / 1 in a CARTON
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