vagisil brand vagistat 2 g/100g

Miconazole nitrate · CREAM · Combe Incorporated

No Recall History

Plain English

Vagisil Brand Vagistat is an over-the-counter vaginal cream containing miconazole nitrate used to treat vaginal yeast infections. It is applied directly into the vagina to relieve itching, burning, and other symptoms of yeast infections.

Key Facts

Brand Name: vagisil brand vagistat
Generic Name: Miconazole nitrate
NDC Code (Product): 11509-0825
Manufacturer: Combe Incorporated
Strength: 2 g/100g
Dosage Form: CREAM
Route: VAGINAL
Marketing Status
Application #: ANDA074760
Marketing Start: 10/08/2020

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: • 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 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 d…

Frequently Asked Questions

What is vagisil brand vagistat used for?

Is vagisil brand vagistat a controlled substance?

vagisil brand vagistat is not classified as a controlled substance by the DEA.

What is the generic name for vagisil brand vagistat?

The generic name for vagisil brand vagistat is Miconazole nitrate. There are 12 other brand versions of Miconazole nitrate.

What is the NDC code for vagisil brand vagistat 2 g/100g?

The NDC (National Drug Code) for vagisil brand vagistat 2 g/100g is 11509-0825, listed by Combe Incorporated.

Product NDC

11509-0825

Package NDC

11509-0825-1

Other Miconazole Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)