Noritate

Noritate is an FDA-registered drug product whose active ingredient is METRONIDAZOLE. It is labelled by Bausch Health US, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 0187-5202, application NDA020743, label effective 20200601. It is one of 53 FDA drug label records sharing the active ingredient METRONIDAZOLE. 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 METRONIDAZOLE are most often described in connection with: usage noritate, topical treatment, inflammatory lesions, erythema rosacea. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

DOSAGE AND ADMINISTRATION Areas to be treated should be cleansed before application of Noritate . Apply and rub in a thin film of Noritate once daily to entire affected area(s). Patients may use cosmetics after application of Noritate .

CONTRAINDICATIONS Noritate is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation.

ADVERSE REACTIONS Safety data from 302 patients who used Noritate (n=200) or vehicle control (n=102) once daily in clinical trials and experienced an adverse event considered to be treatment related include: application site reaction ( Noritate 1, vehicle 1), condition aggravated ( Noritate 1, vehicle 0), paresthesia ( Noritate 0, vehicle 1), acne ( Noritate 1, vehicle 0), dry skin ( Noritate 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity. Two patients treated with Noritate once daily discontinued treatment because of adverse events: one for a severe flare of comedonal acne and one for rosacea aggravated. Additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 53 drug label records with METRONIDAZOLE 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 Noritate used for?
INDICATIONS AND USAGE Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

Who makes Noritate?
Bausch Health US, LLC is the labeler of record for Noritate. 53 FDA label records share the active ingredient METRONIDAZOLE, 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 Noritate 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 Noritate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METRONIDAZOLE?
Yes. 53 FDA drug label records list METRONIDAZOLE 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 Noritate 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.