Lagicam antifungal MICONAZOLE NITRATE GENOMMA LAB USA, INC. FDA Approved Use treats vaginal yeast infections
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Substance Miconazole Nitrate
Route
VAGINAL
Applications
ANDA076773

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Miconazole Nitrate USP 4% (200 mg in each applicator)
Inactive Ingredients
Inactive ingredients cetyl alcohol isopropyl myristate polysorbate 60 polysorbate 80 potassium hydroxide propylene glycol purified water sorbitan monostearate and stearyl alcohol
Strengths
4 % 200 mg
Treats Conditions
Use Treats Vaginal Yeast Infections

Identifiers & Packaging

Container Type BOX
UNII
VW4H1CYW1K
Packaging

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton VAGINAL ANTIFUNGAL Miconazole 3 lagicam ® Miconazole Nitrate Vaginal Cream USP (4%) Vaginal Antifungal (Miconazole Nitrate 200 mg per applicator) Cures most vaginal yeast infections Relieves the symptoms 3 DAY TREATMENT 200 mg per applicator One 0.9 oz (25 g) tube of 3 Day Vaginal Cream with 3 Disposable Applicators Consumer Information Leaflet Enclosed Principal Display Panel - 25 g Tube Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 25 g Tube Carton VAGINAL ANTIFUNGAL Miconazole 3 lagicam ® Miconazole Nitrate Vaginal Cream USP (4%) Vaginal Antifungal (Miconazole Nitrate 200 mg per applicator) Cures most vaginal yeast infections Relieves the symptoms 3 DAY TREATMENT 200 mg per applicator One 0.9 oz (25 g) tube of 3 Day Vaginal Cream with 3 Disposable Applicators Consumer Information Leaflet Enclosed Principal Display Panel - 25 g Tube Carton

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: applicators: 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 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 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

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.

Storage & Handling

Other information store at 20°-25°C (68°-77°F) do not purchase if carton is open see end flaps of carton and end of tube for lot number and expiration date the tube opening should be sealed. If seal has been broken, do not use product.

Questions

Questions or comments? Call toll free 1-877-994-3666 Monday to Friday from 8 am to 6 pm


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