Monistat 1 Combination Pack
- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - Kit Carton
FULL PRESCRIBING INFORMATION
|Miconazole nitrate 1200 mg (in vaginal insert)||Vaginal antifungal|
|Miconazole nitrate 2% (external cream)||Vaginal antifungal|
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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.
- 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
- 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.
- 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
call toll-free 877-666-4782
Distributed by: INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053
PRINCIPAL DISPLAY PANEL - Kit Carton
1 DAY TREATMENT • OVULE ® INSERT
Miconazole Nitrate Vaginal Insert (1200mg) and Miconazole Nitrate Cream (2%)
CURES MOST VAGINAL YEAST INFECTIONS
and relieves associated external itching and irritation
# 1 DOCTOR
Net Wt. 1 OVULE® Insert • 0.32oz (9g) tube
Monistat 1 Combination Pack
Miconazole Nitrate KIT