FDA Label for Monistat 3 Combination Pack
View Indications, Usage & Precautions
Monistat 3 Combination Pack Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Purpose
Miconazole nitrate 4% (200 mg in each applicator) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
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 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.
Directions
- 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 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
- external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
Other Information
- do not use if printed suppository wrapper 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)
Inactive Ingredients
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Questions?
If you have any questions or comments, please call 1-877-666-4782
Principal Display Panel
- Kit Carton
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%)
(Miconazole Nitrate 200 mg per applicator plus 2% external vulvar cream)
VAGINAL ANTIFUNGAL
3 PREFILLED APPLICATORS Net Wt. 0.18 oz. (5g) each applicator
plus External Cream for Itch Relief +0.32 oz. (9g) tube
* Please review the disclaimer below.