Miconazole 7 MICONAZOLE NITRATE P & L DEVELOPMENT, LLC FDA Approved Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
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Substance Miconazole Nitrate
Route
VAGINAL
Applications
ANDA074164
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Miconazole nitrate USP 2% (100 mg in each applicator)
Inactive Ingredients
Inactive ingredients benzoic acid butylated hydroxyanisole mineral oil oleoyl polyoxylglycerides pegoxol 7 stearate purified water
Strengths
2 % 100 mg
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 UNKNOWN
All Product Codes
UNII
VW4H1CYW1K
Packaging

Principal display panel Compare to the active ingredient in Monistat® 7 Vaginal Cream* miconazole 7 miconazole nitrate vaginal cream USP 2% (miconazole nitrate 100 mg per applicator vaginal antifungal cures most vaginal yeast infections relieves associated external itching and irritation net wt. oz (g) tube 7 day vaginal cream (1 tube) + 1 reusable applicator *this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®. Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590; Package label READYinCASE Vaginal Antifungal Miconazole nitrate USP, 2% (100 mg in each applicator

Package Descriptions
  • Principal display panel Compare to the active ingredient in Monistat® 7 Vaginal Cream* miconazole 7 miconazole nitrate vaginal cream USP 2% (miconazole nitrate 100 mg per applicator vaginal antifungal cures most vaginal yeast infections relieves associated external itching and irritation net wt. oz (g) tube 7 day vaginal cream (1 tube) + 1 reusable applicator *this product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®. Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590
  • Package label READYinCASE Vaginal Antifungal Miconazole nitrate USP, 2% (100 mg in each applicator

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
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.

Questions

Questions? Call 1-877-753-3935 Monday–Friday 9AM-5PM EST


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