ACTIVE INGREDIENT

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

PURPOSE

Vaginal antifungal

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

•

•vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.

•

•lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.

•

•been exposed to the human immunodeficiency virus (HIV) that causes AIDS

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

Taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

WHEN USING THIS PRODUCT

•

•do not use tampons, douches, spermicides or other vaginal products

•

•do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).

•

•do not have vaginal intercourse (sex)

•

•mild increase in vaginal burning or irritation may occur

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, 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 the Poison Control Center right away.

DIRECTIONS

•

•before using this product read the enclosed brochure for complete instructions

•

• adults and children 12 years of age and over:

•

• applicator: insert one applicatorful into the vagina at bedtime for 7 days in a row. Wash applicator after each use.

•

• external cream:  squeeze a small amount of cream onto your fingertip.  Gently apply the cream onto the itchy, irritated skin outside the vagina.  Use 2 times daily for up to 7 days as needed.

•

• children under 12 years:  ask a doctor

 

Other Information

• 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.

INACTIVE INGREDIENTS

benzoic acid, BHA, mineral oil, peglicol-5 oleate, pegoxol 7 stearate, purified water

QUESTIONS?

1-800-922-1038

HOW SUPPLIED

Miconazole Nitrate Vaginal Cream USP 2%

45gr – NDC 68788-9772-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL