Miconazole Nitrate MICONAZOLE NITRATE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
FunFoxMeds box
Substance Miconazole Nitrate
Route
VAGINAL
Applications
ANDA074444

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Miconazole nitrate USP 2% (100 mg in each applicatorful)
Inactive Ingredients
Inactive ingredients benzoic acid (0.20%) as a preservative butylated hydroxytoluene mineral oil oleoyl polyoxylglyceride PEG-6-32 stearate/glycol stearate and purified water.
Strengths
2 % 100 mg
Quantities
6 count
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection

Identifiers & Packaging

Container Type BOX
UPC
0351672203566
UNII
VW4H1CYW1K
Packaging

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton CURES most vaginal YEAST INFECTIONS Relieves associated external itching and irritation NDC 51672-2035-6 7 Day Treatment 7 Day Vaginal Cream Miconazole Nitrate Vaginal Cream USP (2%) (Miconazole Nitrate 100 mg per application) Vaginal Antifungal One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%) & 1 Reusable Applicator Consumer Information Leaflet Enclosed PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton CURES most vaginal YEAST INFECTIONS Relieves associated external itching and irritation NDC 51672-2035-6 7 Day Treatment 7 Day Vaginal Cream Miconazole Nitrate Vaginal Cream USP (2%) (Miconazole Nitrate 100 mg per application) Vaginal Antifungal One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%) & 1 Reusable Applicator Consumer Information Leaflet Enclosed PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Overview

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

Indications & Usage

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

Dosage & Administration

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 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to 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

Warnings & Precautions
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 (1-800-222-1222) right away.
Purpose

Purpose Vaginal antifungal

Do Not Use

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

When Using

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 & Ask a Doctor

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.

Keep Out of Reach of Children

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

Storage & Handling

Other information do not purchase if carton is opened do not use if seal over tube opening has been punctured or is not visible store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

Questions

Questions? call 1-866-923-4914


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →