Monistat 1 Combination Pack

Monistat 1 Combination Pack is an FDA-registered drug product whose active ingredient is MICONAZOLE NITRATE. It is labelled by Insight Pharmaceuticals LLC and marketed as a human otc drug product. Identifiers on file: NDC 63736-013, application NDA021308, label effective 20260420. It is one of 70 FDA drug label records sharing the active ingredient MICONAZOLE NITRATE. 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 MICONAZOLE NITRATE are most often described in connection with: vaginal yeast, infections relieves, external itching, irritation due. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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: vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw away applicator. 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 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.

FDA lists 70 drug label records with MICONAZOLE NITRATE 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 1 Combination Pack used for?
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Who makes Monistat 1 Combination Pack?
Insight Pharmaceuticals LLC is the labeler of record for Monistat 1 Combination Pack. 70 FDA label records share the active ingredient MICONAZOLE NITRATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is Monistat 1 Combination Pack 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 MICONAZOLE NITRATE?
Yes. 70 FDA drug label records list MICONAZOLE NITRATE 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 1 Combination Pack 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.