Equaline Miconazole 7 MICONAZOLE NITRATE UNITED NATURAL FOODS, INC. DBA UNFI 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
ANDA074760
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Miconazole nitrate 2%
Inactive Ingredients
Inactive ingredients benzoic acid butylated hydroxyanisole glyceryl stearate mineral oil peglicol 5 oleate pegoxol 7 stearate purified water
Strengths
2 %
Quantities
1 count
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 Monistat ® 7 active ingredient 7-DAY TREATMENT Miconazole-7 vaginal cream miconazole nitrate vaginal cream (2%) vaginal antifungal CREAM WITH 7 DISPOSABLE APPLICATORS COMPARE TO Monistat ® 7 active ingredient 7-DAY TREATMENT Miconazole-7 miconazole nitrate vaginal cream (2%) vaginal antifungal CURES most vaginal YEAST INFECTIONS Relieves associated external itching and irritation NET WT 1.59 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS 825-el-miconazole-7-1 825-el-miconazole-7-2

Package Descriptions
  • Principal Display Panel COMPARE TO Monistat ® 7 active ingredient 7-DAY TREATMENT Miconazole-7 vaginal cream miconazole nitrate vaginal cream (2%) vaginal antifungal CREAM WITH 7 DISPOSABLE APPLICATORS COMPARE TO Monistat ® 7 active ingredient 7-DAY TREATMENT Miconazole-7 miconazole nitrate vaginal cream (2%) vaginal antifungal CURES most vaginal YEAST INFECTIONS Relieves associated external itching and irritation NET WT 1.59 OZ (45 g) TUBE + 7 DISPOSABLE APPLICATORS 825-el-miconazole-7-1 825-el-miconazole-7-2

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: • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away 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 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 • 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 (1-800-222-1222).
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 seal over tube opening has been punctured • do not purchase if carton is open • store at 20°-25°C (68°-77°F)

Questions

Questions or comments? 1-855-423-2630


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