El Valle Gentian Violet

El Valle Gentian Violet is an FDA-registered drug product whose active ingredient is GENTIAN VIOLET 1%. It is labelled by Pharmadel LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 55758-373, application M004, label effective 20260413. 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: 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.

Uses First aid to help prevent infection in minor cuts scrapes burns

Directions clean the affected area apply a small amount directly to the affected area 1 to 3 times a day may cover area with sterile bandage

Warnings FOR EXTERNAL USE ONLY. Do not use longer than 1 week, unless directed by a doctor in the eyes Ask a doctor before use if you have a deep or puncture wounds serious burns animal bites Stop use and consult a doctor if conditions persist or gets worse Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.

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 El Valle Gentian Violet used for?
Uses First aid to help prevent infection in minor cuts scrapes burns

Who makes El Valle Gentian Violet?
Pharmadel LLC is the labeler of record for El Valle Gentian Violet. 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 El Valle 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 El Valle 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.

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 El Valle 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.