Monistat 3 Combination Pack description, usages, side effects, indications, overdosage, supplying and lots more!

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Monistat 3 Combination Pack

Insight Pharmaceuticals

Monistat 3 Triple Action System


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Miconazole nitrate (200 mg in each vaginal insert) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal

Monistat 3 Combination Pack Uses

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a 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 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

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 directions and information
  • adults and children 12 years of age and over:
    • vaginal insert: with the applicator, place the vaginal insert into the vagina at bedtime for 3 nights in a row. Throw away applicator 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

Monistat 3 Combination Pack 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 Monistat 3 Combination Pack is not visible

  • do not purchase if carton is open
  • store at 20°-25°C (68°-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
Miconazole Nitrate Vaginal Inserts (200mg) and Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL

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

COMBINATION PACK

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

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

Monistat 3 Combination Pack

Monistat 3 Combination Pack

Miconazole Nitrate KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-002
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-002-03 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020670 1996-04-16


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Be sure to consult your doctor before taking any medication!
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