Drugplain

MONISTAT 3

Miconazole Nitrate · KIT · Insight Pharmaceuticals LLC

No Recall History
Plain English

MONISTAT 3 is a kit containing miconazole nitrate. Manufactured by Insight Pharmaceuticals LLC.

Key Facts

Brand Name
MONISTAT 3
Generic Name
Miconazole Nitrate
NDC Code (Product)
63736-017
Manufacturer
Insight Pharmaceuticals LLC
Dosage Form
KIT
Marketing Status
Application #
NDA020670
Marketing Start
04/16/1996

Recall History

No Recall History

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: ○ suppositories: insert 1 suppository into the vagina at bedtime for three nights in a row. Throw applicator away after use. ○ 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 p harmacist 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 bette

Frequently Asked Questions

What is MONISTAT 3 used for?

MONISTAT 3 contains Miconazole Nitrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is MONISTAT 3 a controlled substance?

MONISTAT 3 is not classified as a controlled substance by the DEA.

What is the generic name for MONISTAT 3?

The generic name for MONISTAT 3 is Miconazole Nitrate. There are 12 other brand versions of Miconazole Nitrate.

What is the NDC code for MONISTAT 3 ?

The NDC (National Drug Code) for MONISTAT 3 is 63736-017, listed by Insight Pharmaceuticals LLC.