7 DAY VAGINAL description, usages, side effects, indications, overdosage, supplying and lots more!

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7 DAY VAGINAL

Cardinal Health
G & W LABORATORIES, INC.

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

Vaginal antifungal

  • treats repeat vaginal yeast infections

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

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.

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.

  • 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

  • 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.

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

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

7 DAY VAGINAL

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-590
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 2 g

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
Mineral Oil
PEG-5 OLEATE
PEGOXOL 7 STEARATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-590-29 45 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2009-03-16


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Be sure to consult your doctor before taking any medication!
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