4oz

4oz is an FDA-registered drug product whose active ingredient is MICONAZOLE. It is labelled by Nabrace LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84056-003, application M005, label effective 20260418. It is one of 5 FDA drug label records sharing the active ingredient MICONAZOLE. 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 are most often described in connection with: hand sanitizer, help reduce, cause disease. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings For external use only. Flammable. Keep away from heat or flame

FDA lists 5 drug label records with MICONAZOLE 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.

5 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 4oz used for?
Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Who makes 4oz?
Nabrace LLC is the labeler of record for 4oz. 5 FDA label records share the active ingredient MICONAZOLE, 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 4oz 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 4oz 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?
Yes. 5 FDA drug label records list MICONAZOLE 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 4oz been recalled?
5 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.