Drugplain

MONISTAT TIOCONAZOLE 1 6.5 g/100g

TIOCONAZOLE · OINTMENT · Insight Pharmaceuticals LLC

No Recall History
Plain English

MONISTAT TIOCONAZOLE 1 is a ointment containing tioconazole at 6.5 g/100g, taken topical. Manufactured by Insight Pharmaceuticals LLC.

Key Facts

Brand Name
MONISTAT TIOCONAZOLE 1
Generic Name
TIOCONAZOLE
NDC Code (Product)
63736-413
Manufacturer
Insight Pharmaceuticals LLC
Strength
6.5 g/100g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
ANDA075915
Drug Class
Azole Antifungal [EPC]
Marketing Start
11/21/2001

Recall History

No Recall History

Side Effects Reported to FDA

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

vulvovaginal burning sensation523 reports
drug ineffective441 reports
vulvovaginal swelling293 reports
vulvovaginal pain227 reports
condition aggravated225 reports
vulvovaginal pruritus196 reports
vulvovaginal discomfort160 reports
vaginal discharge59 reports
underdose54 reports
hypersensitivity53 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses treats vaginal yeast infections

Dosage & Administration

Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years of age and over: ○ open the foil packet just before use and remove purple cap ○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use. 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 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 disch…

Frequently Asked Questions

What is MONISTAT TIOCONAZOLE 1 used for?

MONISTAT TIOCONAZOLE 1 contains TIOCONAZOLE. It is a ointment taken topical. Consult your doctor for specific uses.

Is MONISTAT TIOCONAZOLE 1 a controlled substance?

MONISTAT TIOCONAZOLE 1 is not classified as a controlled substance by the DEA.

What is the generic name for MONISTAT TIOCONAZOLE 1?

The generic name for MONISTAT TIOCONAZOLE 1 is TIOCONAZOLE. There are 11 other brand versions of TIOCONAZOLE.

What is the NDC code for MONISTAT TIOCONAZOLE 1 6.5 g/100g?

The NDC (National Drug Code) for MONISTAT TIOCONAZOLE 1 6.5 g/100g is 63736-413, listed by Insight Pharmaceuticals LLC.

Product NDC

63736-413

Package NDC

63736-413-01

Other Tioconazole 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)