topcare miconazole 1

topcare miconazole 1 is an FDA-registered drug product whose active ingredient is MICONAZOLE NITRATE. It is labelled by Topco Associates LLC and marketed as a human otc drug product. Identifiers on file: NDC 36800-199, application ANDA079114, label effective 20260811. 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 applicator away. • 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 (1-800-222-1222).

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.

What is topcare miconazole 1 used for?
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

Who makes topcare miconazole 1?
Topco Associates LLC is the labeler of record for topcare miconazole 1. 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 topcare miconazole 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 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 topcare miconazole 1 been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.