MONISTAT TIOCONAZOLE 1

MONISTAT TIOCONAZOLE 1 is an FDA-registered drug product whose active ingredient is TIOCONAZOLE. It is labelled by Insight Pharmaceuticals LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63736-413, application ANDA075915, label effective 20260904. It is one of 8 FDA drug label records sharing the active ingredient TIOCONAZOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TIOCONAZOLE are most often described in connection with: treats vaginal, yeast infections. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses treats vaginal yeast infections

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 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 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).

FDA lists 8 drug label records with TIOCONAZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is MONISTAT TIOCONAZOLE 1 used for?
Uses treats vaginal yeast infections

Who makes MONISTAT TIOCONAZOLE 1?
Insight Pharmaceuticals LLC is the labeler of record for MONISTAT TIOCONAZOLE 1. 8 FDA label records share the active ingredient TIOCONAZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does MONISTAT TIOCONAZOLE 1 come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is MONISTAT TIOCONAZOLE 1 prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TIOCONAZOLE?
Yes. 8 FDA drug label records list TIOCONAZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has MONISTAT TIOCONAZOLE 1 been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.