MONISTAT 3 MICONAZOLE NITRATE INSIGHT PHARMACEUTICALS LLC FDA Approved Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
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Applications
NDA020670
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Act ive ingredients Miconazole nitrate (200 mg in each suppository) Miconazole nitrate 2% (external cream)
Inactive Ingredients
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.
Strengths
200 mg 2 %
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection
Pill Appearance
Shape: bullet Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
Packaging

P RINCIPAL D ISPLAY P ANEL MONISTAT ® 3 COMBINATION PACK Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL 3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL 3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

Package Descriptions
  • P RINCIPAL D ISPLAY P ANEL MONISTAT ® 3 COMBINATION PACK Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL 3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream (2%) VAGINAL ANTIFUNGAL 3 Suppositories Net Wt. 2.5 g each _ 0.32 oz (9 g) Tube

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 three 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 p harmacist 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.
Purpose

Purpose Vaginal antifungal 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.

Questions

Questions? If you have any questions or comments, please call 1-877-666-4782 .


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