Drugplain

Miconazole 7 20 mg/g

Miconazole Nitrate · CREAM · Major Pharmaceuticals

1 Recall on Record
Plain English

Miconazole 7 is a cream containing miconazole nitrate at 20 mg/g, taken vaginal. Manufactured by Major Pharmaceuticals.

Key Facts

Brand Name
Miconazole 7
Generic Name
Miconazole Nitrate
NDC Code (Product)
0904-7734
Manufacturer
Major Pharmaceuticals
Strength
20 mg/g
Dosage Form
CREAM
Route
VAGINAL
Marketing Status
Application #
ANDA074164
Marketing Start
04/21/2009

Recall History

1 Recall on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

vulvovaginal burning sensation568 reports
drug ineffective532 reports
condition aggravated236 reports
vulvovaginal pain206 reports
vulvovaginal pruritus180 reports
vulvovaginal discomfort149 reports
vaginal haemorrhage86 reports
off label use76 reports
vulvovaginal swelling72 reports
hypersensitivity64 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: • 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

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

Frequently Asked Questions

What is Miconazole 7 used for?

Miconazole 7 contains Miconazole Nitrate. It is a cream taken vaginal. Consult your doctor for specific uses.

Is Miconazole 7 a controlled substance?

Miconazole 7 is not classified as a controlled substance by the DEA.

What is the generic name for Miconazole 7?

The generic name for Miconazole 7 is Miconazole Nitrate. There are 12 other brand versions of Miconazole Nitrate.

What is the NDC code for Miconazole 7 20 mg/g?

The NDC (National Drug Code) for Miconazole 7 20 mg/g is 0904-7734, listed by Major Pharmaceuticals.