FDA Label for Monistat 3 Combination Pack 3 Ovule Inserts

Other

Drug Facts

Distributed by: McNEIL-PPC, Inc., Skillman, NJ 08558

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

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 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

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 disease (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

• symptoms do not get better after 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 and over:
  • vaginal insert: with a disposable applicator place the insert into the vagina at bedtime. Throw applicator away after use.
  • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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

• do not use if printed sealed pouches containing vaginal inserts are torn, open, or incompletely sealed

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

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

Inactive Ingredients

• vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide
• external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

If you have any questions or comments, please call 1-877-666-4782

Principal Display Panel - Kit Carton

3 DAY TREATMENT • OVULE^® INSERTS

MONISTAT^® 3
Miconzole Nitrate Vaginal Inserts (200mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

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

COMBINATION PACK

Net Wt. 3 OVULE^® Inserts • 0.32oz (9g) tube