Gentian Violet
Gentian Violet is an FDA drug label for the active ingredient GENTIAN VIOLET manufactured by Vitamex USA, Corp administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260826.
- Generic name
- GENTIAN VIOLET
- Manufacturer
- Vitamex USA, Corp
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 69469-010
- Application
- M003
- Label effective
- 20260826
About this product
Gentian Violet is an FDA-registered drug product whose active ingredient is GENTIAN VIOLET. It is labelled by Vitamex USA, Corp taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69469-010, application M003, label effective 20260826. 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.
What it is used for
Across FDA labelling, products containing GENTIAN VIOLET are most often described in connection with: first aid, help prevent, infection minor, cuts scrapes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses: Uses: First aid to help prevent infection in minor cuts, scrapes and burns.
Dosage & Administration
Directions Directions Clean affected area. Apply a small amount of this product on the area 1 to 3 times daily. Supervise children in the use of this product.
Warnings
Warnings: Warnings: For External Use Only Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor, longer than 1 week unless directed by a doctor.
Frequently asked questions
What is Gentian Violet used for?
Uses: Uses: First aid to help prevent infection in minor cuts, scrapes and burns.
Who makes Gentian Violet?
Vitamex USA, Corp is the labeler of record for Gentian Violet.
What form does Gentian Violet 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 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.
Has Gentian Violet 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.