Gentian Violet 1%

Gentian Violet 1% is an FDA-registered drug product whose active ingredient is GENTIAN VIOLET 1%. It is labelled by Pharma Nobis, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82645-917, application M003, label effective 20260709. It is one of 4 FDA drug label records sharing the active ingredient GENTIAN VIOLET 1%. 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 GENTIAN VIOLET 1% are most often described in connection with: indications first, aid help, protect against, infection minor, cuts scrapes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications First aid to help protect against infection in minor cuts, scrapes, and burns. Indications First aid to help protect against infection in minor cuts, scrapes, and burns. (12/2021)

Directions Clean the affected area and apply directly to the wound or use cotton applicator once or twice daily. Do not bandage.

Warnings For external use only. Do not apply to an ulcerative lesion as this may cause tatooing of the skin. Do not use in the eyes or over large areas of the body.

FDA lists 4 drug label records with GENTIAN VIOLET 1% 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 Gentian Violet 1% used for?
Indications First aid to help protect against infection in minor cuts, scrapes, and burns. Indications First aid to help protect against infection in minor cuts, scrapes, and burns. (12/2021)

Who makes Gentian Violet 1%?
Pharma Nobis, LLC is the labeler of record for Gentian Violet 1%. 4 FDA label records share the active ingredient GENTIAN VIOLET 1%, 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 Gentian Violet 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 Gentian Violet 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 GENTIAN VIOLET 1%?
Yes. 4 FDA drug label records list GENTIAN VIOLET 1% 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 Gentian Violet 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.