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Monistat 3

Insight Pharmaceuticals

Monistat® 3 Day Vaginal Cream in Prefilled Applicators


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Miconazole nitrate 4% (200 mg in each applicatorful)

Purpose

Vaginal antifungal

Use

  • treats vaginal yeast infections

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 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 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

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

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 and over:
    • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
  • children under 12 years of age: ask a doctor

Monistat 3 Other information

  • do not use if printed applicator wrapper is torn, open or incompletely sealed
  • 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 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

3 DAY TREATMENT • CREAM

MONISTAT ® 3
Miconazole Nitrate Vaginal Cream (4%)
(Miconazole Nitrate 200 mg per applicator)
VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS

CLINICALLY PROVEN
3 DAY TREATMENT

CLASSIC

#1 DOCTOR
RECOMMENDED BRAND

Net Wt. 0.18 oz. (5g) each applicator

Monistat 3

Monistat 3

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-015
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 40 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
CETYL ALCOHOL
ISOPROPYL MYRISTATE
POLYSORBATE 60
POTASSIUM HYDROXIDE
propylene glycol
water
stearyl alcohol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 TUBE, WITH APPLICATOR
2 NDC:63736-015-18 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020827 1998-03-30


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Be sure to consult your doctor before taking any medication!
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