Miconazole 3 MICONAZOLE NITRATE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED FDA Approved Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
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Applications
ANDA075329

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Miconazole nitrate (200 mg in each suppository) Miconazole nitrate 2% (external cream)
Inactive Ingredients
Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid butylated hydroxyanisole glyceryl stearate mineral oil peglicol 5 oleate pegoxol 7 stearate purified water
Strengths
200 mg 2 %
Quantities
3 count
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
Packaging

Principal Display Panel CVS Health ® Compare to the active ingredients in Monistat ® 3 3-Day Treatment Miconazole 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg & MICONAZOLE NITRATE VAGINAL CREAM, USP 2% Vaginal Antifungal Suppository Combination Pack • CURES most vaginal YEAST INFECTIONS • Relieves associated external itching & irritation • Suppositories contain just two ingredients 3 Vaginal suppositories with disposable applicators plus external cream for itch 3 SUPPOSITORIES | NET WT 2.5 g EACH 1 TUBE | NET WT 0.32 OZ (9 g) cvshealth-miconazole-3-carton-image.jpg

Package Descriptions
  • Principal Display Panel CVS Health ® Compare to the active ingredients in Monistat ® 3 3-Day Treatment Miconazole 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg & MICONAZOLE NITRATE VAGINAL CREAM, USP 2% Vaginal Antifungal Suppository Combination Pack • CURES most vaginal YEAST INFECTIONS • Relieves associated external itching & irritation • Suppositories contain just two ingredients 3 Vaginal suppositories with disposable applicators plus external cream for itch 3 SUPPOSITORIES | NET WT 2.5 g EACH 1 TUBE | NET WT 0.32 OZ (9 g) cvshealth-miconazole-3-carton-image.jpg

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: • suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw applicator away 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

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 right away (1-800-222-1222).
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 right away (1-800-222-1222).

Storage & Handling

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)

Questions

Questions or comments? 1-800-719-9260


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