Gentian Violet 2% Solution
FDA Label NDC 54633-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Podiatree Company for the product Gentian Violet 2% (NDC 54633-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, do not use, stop use and ask a doctor or pharmacist, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor Or Pharmacist

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Suggestions?

→ Principal Display Panel

Active Ingredient

Gentian Violet 2%

Purpose

Antiseptic

First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns

Warnings

For external use only

Do Not Use

in eyes; with bandages; on large areas of the body; longer than one week unless directed by a doctor; stop use and consult a doctor if condition persists; in case of deep puncture wounds, animal bites or serious burns, consult a doctor; if known to be sensitive to any ingredients in the product; do not apply to ulcerative lesions as this may result in tattooing of the skin.