Miconazole Nitrate

Taro Pharmaceuticals U.S.A., Inc.

Miconazole Nitrate

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Miconazole Nitrate Uses
• Warnings
• Directions
• Miconazole Nitrate Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 45 g 1 Reusable Applicator Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Miconazole Nitrate USP 2% (100 mg per applicator)

Purpose

Vaginal Antifungal

Miconazole Nitrate Uses

• treats vaginal yeast infections
• relieves external itching and irritation due to a 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 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 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

If pregnant or breast-feeding, ask a health professional before use.

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

Miconazole Nitrate Other information

• do not purchase if carton is opened
• do not use if seal over tube opening has been punctured or is not visible

To open: unscrew cap, use pointed end on cap to puncture seal

To close: screw cap back onto the tube

• store at 20°-25°C (68°-77°F)
• see carton or tube crimp for lot number and expiration date

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

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 45 g 1 Reusable Applicator Carton

Cures Most Vaginal Yeast Infections
and Relieves Associated External Itching and Irritation

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)

One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator

Educational Brochure Enclosed