Gentian Violet

Approved indications

• Topical antifungal infections: Candida species infections of skin, mucous membranes, and nails.
• Bacterial infections (limited use): Minor skin infections caused by Gram-positive bacteria such as Staphylococcus aureus.
• Oral thrush: Candida-associated oral infections in infants and immunocompromised patients.
• Otomycosis and external ear infections: Fungal or mixed microbial infections in the ear canal.
• Minor wounds and abrasions: Used as antiseptic to prevent secondary infection.
• Dermatological conditions: Intertrigo, diaper rash with fungal involvement.

Off-label / clinically accepted uses

• Treatment of certain protozoal infections such as Trypanosoma and Leishmania in topical formulations.
• Adjunct therapy for fungal infections resistant to standard antifungal agents.

Topical application

• Skin infections: Apply a thin layer 1–2 times daily to the affected area.
• Oral thrush (infants): Apply 0.5–1 mL to oral mucosa 1–2 times daily; wipe off excess after a few minutes to minimize staining.
• Ear infections (otic): Instill 1–2 drops 2–3 times daily into the affected ear.

Duration

• Typically 3–7 days for minor infections; may extend to 2 weeks for persistent or severe cases.

Special populations

• Pediatrics: Use lower concentrations (0.5–1%) for infants to reduce irritation and staining.
• Elderly: Standard topical dosing; monitor for skin sensitivity.
• Renal/Hepatic impairment: Not systemically absorbed in significant amounts; no dose adjustment typically required.

Gentian violet is a triphenylmethane dye with potent antimicrobial properties. It binds to bacterial and fungal DNA, causing inhibition of cell wall synthesis and disruption of nucleic acid replication. This leads to bacterial and fungal cell death. It also exerts oxidative stress on microbial membranes, enhancing its antiseptic effects. The compound is primarily active against Gram-positive bacteria and yeasts, with limited effect on Gram-negative bacteria.

• Absorption: Minimal systemic absorption when applied topically; oral or mucosal absorption is low.
• Distribution: Concentrates in superficial skin and mucosal layers.
• Metabolism: Limited; some degradation may occur by skin enzymes.
• Elimination: Excreted mainly in feces when ingested; negligible renal excretion after topical use.
• Onset: Antimicrobial effect is immediate upon contact with affected tissue.
• Half-life: Not clinically significant due to minimal systemic absorption.

• Pregnancy: Category C; topical use is generally considered low risk, but systemic exposure should be avoided.
• Breastfeeding: Limited systemic absorption suggests low risk; avoid application to the breast if infant may ingest the dye.
• Caution: Data in humans are limited; use only when potential benefit outweighs risk.

• Primary class: Antiseptic / Antimicrobial agent
• Subclass: Topical antifungal and antibacterial dye

• Known hypersensitivity to gentian violet or triphenylmethane dyes.
• Open or deep wounds requiring systemic therapy (topical use alone insufficient).
• Application to mucosa where ingestion or systemic absorption could occur at high doses.

• Skin irritation: May cause redness, burning, or itching.
• Staining: Skin, mucosa, nails, and clothing may be permanently stained purple.
• Carcinogenic potential: High systemic doses in animal studies showed tumorigenic effects; avoid prolonged systemic exposure.
• High-risk groups: Infants and pregnant women—use minimal amounts and monitor for local reactions.
• Monitoring: Inspect skin and mucosa for excessive irritation during treatment.

Common

• Local irritation, redness, and burning sensation.
• Purple staining of skin, nails, hair, and clothing.

Serious / rare

• Allergic dermatitis or rash.
• Ulceration with prolonged or excessive use.
• Rare systemic toxicity if ingested or used on large areas of broken skin.

Onset

• Immediate local effects; staining occurs within minutes of application.

• No significant systemic interactions due to minimal absorption.
• May interfere with topical antiseptics or dyes applied simultaneously.
• Avoid concurrent use with oxidizing agents (e.g., hydrogen peroxide) as it may inactivate gentian violet.

• Usage trend: Primarily reserved for topical fungal infections resistant to first-line agents.
• Safety guidance: Avoid oral or systemic ingestion; topical use preferred in low concentrations.
• Regulatory caution: Some agencies recommend limiting prolonged or widespread application due to potential mutagenicity.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep container tightly closed when not in use.
• Keep out of reach of children and avoid contact with clothing and fabrics.
• For liquid formulations, shake gently before application if necessary.