FDA Label for Monistat 3 3 Day
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DO NOT USE IF
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 5 G TUBE CARTON
Monistat 3 3 Day 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.
Active Ingredient
Miconazole nitrate 4% (200 mg in each applicatorful)
Purpose
Vaginal antifungal
Use
- treats vaginal yeast infections
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 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 disease (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 after 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 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
- do not use if printed applicator wrapper is torn, open or incompletely sealed
- do not purchase if carton is open
- store at 20° - 25°C (68° to 77°F)
Inactive Ingredients
benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Questions?
Call toll-free 877-666-4782 or 215-273-8755 (collect)
Principal Display Panel - 5 G Tube Carton
3 DAY TREATMENT • CREAM
MONISTAT® 3
Miconazole Nitrate Vaginal Cream (4%)
(Miconazole Nitrate 200 mg per applicator)
VAGINAL ANTIFUNGAL
Net Wt. 0.18 oz. (5g) each applicator
* Please review the disclaimer below.