SPL UNCLASSIFIED SECTION.


Drug Facts.

OTC - WHEN USING SECTION.


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 occurif you do not get complete relief ask doctor before using another 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 doctor before using another product.

DOSAGE & ADMINISTRATION SECTION.


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:applicator: insert applicatorful into the vagina at bedtime for nights in row. Wash applicator after use.use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use times daily for up to days as needed. children under 12 years of age: ask doctor. before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over:applicator: insert applicatorful into the vagina at bedtime for nights in row. Wash applicator after use.use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use times daily for up to days as needed. applicator: insert applicatorful into the vagina at bedtime for nights in row. Wash applicator after use.. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use times daily for up to days as needed. children under 12 years of age: ask doctor.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol stearate, purified water.

INDICATIONS & USAGE SECTION.


Uses. treats vaginal yeast infections relieves external itching and irritation due to vaginal yeast infection. treats vaginal yeast infections relieves external itching and irritation due to vaginal yeast infection.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient. Miconazole nitrate, USP 2% (100 mg in each applicator).

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. vaginal itching and discomfort for the first timelower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have more serious condition.vaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS. 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 more serious condition.. vaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

OTC - DO NOT USE SECTION.


Do not use. if you have never had vaginal yeast infection diagnosed by doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Vaginal antifungal.

OTC - QUESTIONS SECTION.


Questions. Call 1-800-616-2471.

OTC - STOP USE SECTION.


Stop use and ask doctor if. symptoms do not get better in days symptoms last more than days you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. symptoms do not get better in days symptoms last more than days you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal display panel. Compare to the active ingredient in Monistat(R) Vaginal CreamMiconazole 7Miconazole Nitrate Vaginal Cream, USP 2%(Miconazole Nitrate 100 mg per applicator)2%Vaginal AntifungalCures most vaginal yeast infectionsRelieves associated external itching and irritation7 day vaginal cream (1 tube) with reusable applicatorNET WT OZ (g) Tube This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat(R).Distributed by:MAJOR PHARMACEUTICALSLivonia, MI 48152.

WARNINGS SECTION.


Warnings. For vaginal use only. Do not use. if you have never had vaginal yeast infection diagnosed by doctor. Ask doctor before use if you have. vaginal itching and discomfort for the first timelower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have more serious condition.vaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS. 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 more serious condition.. vaginal yeast infections often (such as once month or in months). You could be pregnant or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS. Ask 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 occurif you do not get complete relief ask doctor before using another 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 doctor before using another product.. Stop use and ask doctor if. symptoms do not get better in days symptoms last more than days you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. symptoms do not get better in days symptoms last more than days you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.