FDA Label for Miconazole 7

Other

Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Active Ingredient

Miconazole Nitrate USP 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

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

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

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:
  • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each 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 purchase if carton is opened
• do not use if seal over tube opening has been punctured or is not visible

  To open: unscrew cap, use pointed end on cap to puncture seal

  To close: screw cap back onto the tube

• store at 20°-25°C (68°-77°F)
• see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

Questions?

Call 1-866-923-4914

Principal Display Panel - 45 G Tube Carton

CVSHealth_™

Compare to the active ingredient in Monistat^® 7 Vaginal Cream*

7-Day Treatment

Miconazole 7

MICONAZOLE NITRATE VAGINAL CREAM USP (2%)
(MICONAZOLE NITRATE 100 mg PER APPLICATOR)

Vaginal antifungal

ONE 45 G (1.5 OZ) TUBE OF MICONAZOLE
NITRATE VAGINAL CREAM USP (2%)
& 7 DISPOSABLE APPLICATORS

NET WT 1.5 OZ (45 g) TUBE

Educational Brochure Enclosed

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton - miconazole 7 01