Drugplain

miconazole 1

Miconazole nitrate · KIT · Meijer Distribution Inc

No Recall History
Plain English

Miconazole 1 is an over-the-counter antifungal medication used to treat fungal infections such as athlete's foot, jock itch, and ringworm. It comes as a kit with application materials for treating the affected skin area as directed.

Key Facts

Brand Name
miconazole 1
Generic Name
Miconazole nitrate
NDC Code (Product)
41250-199
Manufacturer
Meijer Distribution Inc
Dosage Form
KIT
Marketing Status
Application #
ANDA079114
Marketing Start
06/11/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vulvovaginal burning sensation890 reports
drug ineffective718 reports
condition aggravated324 reports
vulvovaginal pain319 reports
vulvovaginal pruritus261 reports
vulvovaginal discomfort204 reports
vaginal haemorrhage121 reports
vulvovaginal swelling113 reports
off label use102 reports
hypersensitivity84 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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: • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away. • external cream: 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

Warnings For vaginal use only Do not use 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

Frequently Asked Questions

What is miconazole 1 used for?

Miconazole 1 is an over-the-counter antifungal medication used to treat fungal infections such as athlete's foot, jock itch, and ringworm. It comes as a kit with application materials for treating the affected skin area as directed.

Is miconazole 1 a controlled substance?

miconazole 1 is not classified as a controlled substance by the DEA.

What is the generic name for miconazole 1?

The generic name for miconazole 1 is Miconazole nitrate. There are 11 other brand versions of Miconazole nitrate.

What is the NDC code for miconazole 1 ?

The NDC (National Drug Code) for miconazole 1 is 41250-199, listed by Meijer Distribution Inc.