Miconazole Nitrate
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Miconazole nitrate USP 2% (100 mg in each applicatorful)
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 SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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
- 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° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredients
benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.
Questions?
call 1-866-923-4914
SPL UNCLASSIFIED SECTION
Distributed by:Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532
HOW SUPPLIED
Product: 50090-4356
NDC: 50090-4356-0 45 g in a TUBE, WITH APPLICATOR / 1 in a CARTON