Monistat 3 3 Day MICONAZOLE NITRATE INSIGHT PHARMACEUTICALS LLC FDA Approved Use treats vaginal yeast infections
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Substance Miconazole Nitrate
Route
VAGINAL
Applications
NDA020827

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Miconazole nitrate 4%
Inactive Ingredients
Inactive ingredients benzoic acid cetyl alcohol isopropyl myristate polysorbate 60 potassium hydroxide propylene glycol purified water stearyl alcohol
Strengths
4 %
Treats Conditions
Use Treats Vaginal Yeast Infections

Identifiers & Packaging

Container Type BOX
UNII
VW4H1CYW1K
Packaging

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT ® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 5 g Tube Carton 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT ® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each 3-DAY TREATMENT Prefilled Cream Applicator MONISTAT® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

Overview

Use treats vaginal yeast infections

Indications & Usage

Use treats vaginal yeast infections

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: ▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. 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 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 disease (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 after 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

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 disease (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 after 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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