Miconazole 3 Combination Pack MICONAZOLE NITRATE RITE AID CORPORATION FDA Approved Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
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Applications
ANDA074926
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients Miconazole nitrate USP 200 mg (in each suppository) Miconazole nitrate USP 2% (external cream)
Inactive Ingredients
Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid butylated hydroxyanisole mineral oil oleoyl polyoxylglycerides pegoxol 7 stearate purified water
Strengths
200 mg 2 %
Treats Conditions
Uses Treats Vaginal Yeast Infections Relieves External Itching And Irritation Due To A Vaginal Yeast Infection

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0011822358248
Packaging

Principal display panel Compare to the active ingredient in Monistat® 3* COMBINATION PACK Miconazole 3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg & Miconazole Nitrate Vaginal Cream, USP Cream, USP 2% VAGINAL ANTIGUNGAL 3 - DAY TREATMENT Vaginal suppositories with 3 disposable applicators plus external cream for itch relief Cures most vaginal yeast infections Relieves associated external itching and irritation 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg WITH 3 DISPOSABLE APPLICATORS PLUS 1 TUBE OF MICONAZOLE NITRATE VAGINAL CREAM, USP 2% NET WT OZ (g) *This product is not affiliated with, manufactured by, or produced by the makers or owners or Monistat®3. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com; Package label RITE AID Vaginal Treatment Miconazole Nitrate, USP 200 mg (in each suppository), Miconazole Nitrate, USP 2% (external cream)

Package Descriptions
  • Principal display panel Compare to the active ingredient in Monistat® 3* COMBINATION PACK Miconazole 3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg & Miconazole Nitrate Vaginal Cream, USP Cream, USP 2% VAGINAL ANTIGUNGAL 3 - DAY TREATMENT Vaginal suppositories with 3 disposable applicators plus external cream for itch relief Cures most vaginal yeast infections Relieves associated external itching and irritation 3 MICONAZOLE NITRATE VAGINAL SUPPOSITORIES, USP 200 mg WITH 3 DISPOSABLE APPLICATORS PLUS 1 TUBE OF MICONAZOLE NITRATE VAGINAL CREAM, USP 2% NET WT OZ (g) *This product is not affiliated with, manufactured by, or produced by the makers or owners or Monistat®3. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com
  • Package label RITE AID Vaginal Treatment Miconazole Nitrate, USP 200 mg (in each suppository), Miconazole Nitrate, USP 2% (external cream)

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: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently 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 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 (1-800-222-1222) 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

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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