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 Physicians Total Care, Inc.. 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.
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only
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:
- suppositories: 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 blister is torn, open or incompletely sealed
do not use if seal over tube opening has been punctured or embossed design
is not visible- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
suppository: hydrogenated vegetable oil base
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Principal Display Panel
54868-4238-0
MONISTAT® 3
COMBINATION PACK
Miconazole Nitrate Vaginal Suppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal
(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)
CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION
ORTHO
3 Vaginal Suppositories with Disposable
Applicators plus External Cream
Net Wt. 3 Suppositories
0.32 oz (9g) tube
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.