FDA Label for Monistat 7 With Reusable Applicator

Other

Drug Facts

Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053

Active Ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

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 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 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

Otc - Stop Use

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 of age and over:
  • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use.
  • Use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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 seal over tube opening has been punctured
• do not purchase if carton is open
• store at 20° - 25°C (68° to 77°F)

Inactive Ingredients

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

Questions?

call toll-free 877-666-4782

Principal Display Panel - 45G Tube Carton

7 DAY TREATMENT • CREAM

MONISTAT^® 7
Miconazole Nitrate Vaginal Cream (2%)
(Miconazole Nitrate 100 mg per application)
VAGINAL ANTIFUNGAL

CLINICALLY PROVEN
7 DAY TREATMENT

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

CLASSIC

Net Wt. 1.59 oz. (45g) tube

#1 DOCTOR
RECOMMENDED BRAND^†