FDA Label for Monistat 3 Combination Pack

Otc - Purpose

Uses

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

Warnings

For vaginal use only

Otc - Do Not Use

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Otc - Ask 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

Otc - When Using

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.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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:
• suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
• external cream: squeeze a small amount of cream onto your fingertip. 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 of age: ask a doctor

Other Information

• do not use if printed suppository blister is torn, open or incompletely sealed

• do not use if seal over tube opening has been punctured or embossed design

  embossed design - monistat 01

  is not visible

• do not purchase if carton is open
• store at 20°-25°C (68°-77°F)

Inactive Ingredients

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Otc - Questions

Questions? If you have any questions or comments, please call 1-877-666-4782
Visit our website @ www.monistat.com

Principal Display Panel - Kit Carton

3 DAY TREATMENT • SOFT INSERTS

MONISTAT^® 3
Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

COMBINATION PACK

Net Wt. 3 Suppositories • 0.32 oz. (9g) tube

Principal Display Panel - Kit Carton - monistat 02