FDA Label for 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 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 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

Principal Display Panel - 45 G Tube Label

CommUnityCare Federally Qualified Health Centers

MICONAZOLE
2% VAGINAL
CREAM

Date:

Name:
Dr.

USE AS DIRECTED

123456

1/1/01

MICONAZOLE 2% VAG.CRM 45gNDC 76413-318-45

Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel - 45 g Tube Label - miconazole 01