Miconazole 3

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 4%

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Use

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections

Warnings

WARNINGS SECTION

For vaginal use only

OTC - DO NOT USE SECTION

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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 SECTION

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

When using this product

OTC - WHEN USING SECTION

• 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:

OTC - STOP USE SECTION

• 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 SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• before using this product read the enclosed consumer information leaflet for complete directions and information
• adults and children 12 years of age and over:
  • 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

Other information

STORAGE AND HANDLING SECTION

• do not use if seal over tube opening has been punctured
• do not purchase if carton is open
• store at 20° to 25°C (68° to 77°F)
• see end flaps of carton and end of tube for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Dist. by Target Corp., Mpls., MN 55403

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11673-391-06

Compare to the active ingredient in Monistat ^®3*

up&up

3-day treatment
miconazole 3
miconazole nitrate vaginal cream USP (4%)
vaginal antifungal

cures most vaginal yeast infections

ONE 0.9 OZ (25 g) TUBE OF 3 DAY VAGINAL CREAM AND THREE DISPOSABLE APPLICATORS

DailyMed RxNorm Mappings#

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DailyMed Package Descriptions#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Miconazole 3
• Miconazole Nitrate
• CETYL ALCOHOL
• ISOPROPYL MYRISTATE
• POLYSORBATE 60
• POLYSORBATE 80
• POTASSIUM HYDROXIDE
• PROPYLENE GLYCOL
• WATER
• SORBITAN MONOSTEARATE
• STEARYL ALCOHOL
• MICONAZOLE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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Orange Book products#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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