Topco Miconazole 3 MICONAZOLE NITRATE TOPCO ASSOCIATES LLC FDA Approved Uses • treats vaginal yeast infections
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Substance Miconazole Nitrate
Route
VAGINAL
Applications
ANDA091366
Package NDC

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 %
Quantities
1 count
Treats Conditions
Uses Treats Vaginal Yeast Infections
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
VW4H1CYW1K
Packaging

Package/Label Principal Display Panel 3-DAY TREATMENT CREAM 3 Ready-to-Use Prefilled Disposable Cream Applicators Prefilled Cream Applicator COMPARE TO MONISTAT ® 3 ACTIVE INGREDIENT 3-DAY TREATMENT Miconazole 3 MICONAZOLE NITRATE VAGINAL CREAM (4%) VAGINAL ANITFUNGAL CURES Most Vaginal YEAST INFECTIONS 3 PREFILLED APPLICATORS NET WT. 0.18 OZ (5 g) EACH 07088-micon-image1 07088-micon-image2

Package Descriptions
  • Package/Label Principal Display Panel 3-DAY TREATMENT CREAM 3 Ready-to-Use Prefilled Disposable Cream Applicators Prefilled Cream Applicator COMPARE TO MONISTAT ® 3 ACTIVE INGREDIENT 3-DAY TREATMENT Miconazole 3 MICONAZOLE NITRATE VAGINAL CREAM (4%) VAGINAL ANITFUNGAL CURES Most Vaginal YEAST INFECTIONS 3 PREFILLED APPLICATORS NET WT. 0.18 OZ (5 g) EACH 07088-micon-image1 07088-micon-image2

Overview

Uses • treats vaginal yeast infections

Indications & Usage

Uses • 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
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 applicator wrapper is torn, open, or incompletely sealed • do not purchase if carton is open • store at 20°-25°C (68°-77°F)

Questions

Questions or comments? 1-888-423-0139


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