Drugplain

MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit

Miconazole nitrate · KIT · Cosette Pharmaceuticals, Inc.

No Recall History
Plain English

MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit is a kit containing miconazole nitrate. Manufactured by Cosette Pharmaceuticals, Inc..

Key Facts

Brand Name
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit
Generic Name
Miconazole nitrate
NDC Code (Product)
0713-0593
Manufacturer
Cosette Pharmaceuticals, Inc.
Dosage Form
KIT
Marketing Status
Application #
ANDA074926
Marketing Start
01/03/2025

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 3 nights in a row. Throw applicator away after use. • external cream: use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Apply to 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 Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal

Frequently Asked Questions

What is MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit used for?

MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit contains Miconazole nitrate. It is a kit taken as directed. Consult your doctor for specific uses.

Is MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit a controlled substance?

MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit is not classified as a controlled substance by the DEA.

What is the generic name for MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit?

The generic name for MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit is Miconazole nitrate. There are 12 other brand versions of Miconazole nitrate.

What is the NDC code for MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit ?

The NDC (National Drug Code) for MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit is 0713-0593, listed by Cosette Pharmaceuticals, Inc..