TopCare

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% (200 mg in each applicatorful)

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 are taking 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 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:
  • 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

Other information

STORAGE AND HANDLING SECTION

• store at 20°-25°C (68°-77°F)
• do not purchase if carton is open
• see end flaps of carton and end of tube for lot number and expiration date
• the tube opening should be sealed. If seal has been broken, do not use product.

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 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare
health_™

NDC 36800-070-09

COMPARE TO MONISTAT^® 3
ACTIVE INGREDIENT*

3-DAY TREATMENT

Miconazole 3

MICONAZOLE NITRATE VAGINAL CREAM USP (4%)
(MICONAZOLE NITRATE 200 MG PER APPLICATOR)

VAGINAL ANTIFUNGAL

• CURES Most Vaginal YEAST INFECTIONS

Consumer Information Leaflet Enclosed

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

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Products#

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

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

• TopCare Miconazole 3 Yeast Infection Relief
• Miconazole Nitrate
• Miconazole
• cetyl alcohol
• isopropyl myristate
• polysorbate 60
• polysorbate 80
• potassium hydroxide
• propylene glycol
• water
• sorbitan monostearate
• stearyl alcohol

NDC Codes#

Ingredients#

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

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 5 · 246 matching rows.

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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Current product rows page 1 of 1 · 1 matching rows.

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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