miconazole nitrate

FDA Drug Profile — miconazole 3, HERS Miconazole 3, Topco Miconazole 3, GOOD SENSE MICONAZOLE 3, Miconazole

Drug Details

Generic Name
miconazole nitrate
Brand Names
miconazole 3, HERS Miconazole 3, Topco Miconazole 3, GOOD SENSE MICONAZOLE 3, Miconazole, signature care miconazole 7, fungoid tincture, basic care miconazole 3, Medline
Application Number
ANDA091366
Sponsor
FDC Limited
NDC Codes
13
Dosage Forms
POWDER, CREAM, KIT, TINCTURE, SUPPOSITORY
Routes
VAGINAL, TOPICAL
Active Ingredients
MICONAZOLE NITRATE

Indications and Usage

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

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 not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).