Miconazole Nitrate Vaginal Cream USP (2%)

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SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 2% (100 mg in each applicatorful)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

• 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 aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Product of Italy

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

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

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

Consumer Information Leaflet Enclosed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal

Net Wt. 1.59 oz (45 g) Tube + 1 Reusable Applicator

miconazole

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• Miconazole Nitrate
• MICONAZOLE
• BUTYLATED HYDROXYTOLUENE
• MINERAL OIL
• WATER
• BENZOIC ACID

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