Miconazole nitrate

ACTIVE INGREDIENT

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

PURPOSE

Vaginal antifungal

USES

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

WARNINGS

For vaginal use onlyDo not use if you have never had a vaginal yeast infection diagnosed by a doctorAsk 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 medication warfarin, because bleeding or bruising may occur.When using this product • do not use tampons, douches, spermicides, or other vaginal products • do not have vaginal intercourse • condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)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

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.

DOSAGE & ADMINISTRATION

• before using this product read the enclosed consumer information leaflet for complete instructions• adults and children 12 years of age and over:         • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row         • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated               skin outside the vagina. Use daily for up to 7 days as needed• children under 12 years of age: 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 INGREDIENT

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