FDA Label for 7 Day Vaginal

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.

Directions

• 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 Ingredients

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Questions?

1-800-200-6313

Principal Display Panel

NDC 37205-590-29

LEADER^®

7 DAY VAGINAL CREAM
Miconazole NitrateVAGINAL CREAM 2% • VAGINAL ANTIFUNGAL

Cures most vaginal yeast infections.
Relieves external vulvar itching and irritation associated with a yeast infection

Compare to Monistat^® 7 active ingredient^*

NET WT 1.59 OZ (45 g)

SATISFACTION GUARANTEED

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OH 43017
CIN 1362490

www.myleader.com
1-800-200-6313

All Leader^® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

^*This product is not manufactured or distributed by Johnson & Johnson, distributor or manufacturer of MONISTAT^® 7. MONISTAT^® 7 is a registered trademark of Johnson & Johnson.

10-25237LR2

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