Monistat 1 Combination Pack

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Miconazole nitrate 1200 mg (in vaginal insert)	Vaginal antifungal
Miconazole nitrate 2% (external cream)	Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

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

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.

OTC - ASK DOCTOR SECTION

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

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:
  • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away 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

Other information

STORAGE AND HANDLING SECTION

• do not use if printed sealed pouch is torn, open or incompletely sealed
• do not use if seal over tube opening has been punctured
• do not purchase if carton is open
• store at 20°-25°C (68°-77°F)
• this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.

Inactive ingredients

INACTIVE INGREDIENT SECTION

vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

call toll-free 877-666-4782

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONISTAT^®

Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%)

VAGINAL ANTIFUNGAL | COMBINATION PACK

CLINICALLY PROVEN
MULTI-SYMPTOM RELIEF

#1 DOCTOR
RECOMMENDED BRAND^†

• CURES most vaginal YEAST INFECTIONS
• Relieves associated external itching and irritation

1
1-DAY

MAXIMUM
STRENGTH

TREATMENT
OVULE^®

Net Wt. 1 OVULE^® Insert • 0.32oz (9g) tube

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

• Monistat 1 Combination Pack Triple Action
• Miconazole Nitrate
• Miconazole
• Gelatin
• Glycerin
• Mineral Oil
• Titanium Dioxide
• Petrolatum
• Benzoic Acid
• Cetyl Alcohol
• Isopropyl Myristate
• Polysorbate 60
• Potassium Hydroxide
• Propylene Glycol
• Water
• Stearyl Alcohol

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

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Inactive ingredient matches#

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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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