Drugplain

Goodnow Miconazole 1

Miconazole nitrate · KIT · Gobrands, Inc

No Recall History
Plain English

Goodnow Miconazole 1 is a kit containing miconazole nitrate. Manufactured by Gobrands, Inc.

Key Facts

Brand Name
Goodnow Miconazole 1
Generic Name
Miconazole nitrate
NDC Code (Product)
82501-0199
Manufacturer
Gobrands, Inc
Dosage Form
KIT
Marketing Status
Application #
ANDA079114
Marketing Start
03/26/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

vulvovaginal burning sensation174 reports
drug ineffective130 reports
off label use59 reports
vulvovaginal pain59 reports
condition aggravated58 reports
drug interaction58 reports
vulvovaginal pruritus53 reports
international normalised ratio increased41 reports
constipation39 reports
pain39 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 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

Frequently Asked Questions

What is Goodnow Miconazole 1 used for?

Goodnow Miconazole 1 contains Miconazole nitrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is Goodnow Miconazole 1 a controlled substance?

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

What is the generic name for Goodnow Miconazole 1?

The generic name for Goodnow Miconazole 1 is Miconazole nitrate. There are 12 other brand versions of Miconazole nitrate.

What is the NDC code for Goodnow Miconazole 1 ?

The NDC (National Drug Code) for Goodnow Miconazole 1 is 82501-0199, listed by Gobrands, Inc.