Gentian violet is an antiseptic dye used to treat fungal infections of the skin (such as ringworm, athlete's foot). It also has weak antibacterial effects and may be used on minor cuts and scrapes to prevent infection.

This product has been withdrawn from the Canadian market due to safety problems.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Your doctor may also prescribe this medication for fungal infections of the mouth (thrush).

Follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

Before use, clean the affected area, rinse well, and pat dry. Make sure the area is dry before using this medication. Using a cotton swab to avoid staining your hands, apply gentian violet to the affected area, usually once or twice a day or as directed by your doctor. Apply only to the affected area, and avoid surrounding healthy skin.

Wash hands immediately after use unless the area being treated includes the hands. Avoid getting the product in your eyes. If the medication gets into your eyes, rinse the area immediately with clean water for at least 15 minutes. Seek medical attention if your eye becomes irritated.

Do not cover the area with plastic or waterproof bandages. Covering the area may increase the risk of skin irritation.

This product is for use on the outside of the body only. Do not apply inside the mouth, nose, or ears unless directed by your doctor. This medication is a dye and will stain skin and clothing. Do not apply to open sores (skin ulcers). This may cause permanent "tattooing" of the skin.

If your doctor has prescribed this medication for areas in the mouth, you/your child must be careful to avoid swallowing the medication. If you have any questions about proper use, ask your health care professional.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. If your doctor has prescribed this medication, continue to use it until the full prescribed amount is finished, even if symptoms improve after a few days. Stopping the medication too early may allow the infection to return.

Tell your doctor if the condition does not get better in 3 days or if it gets worse. If you think you may have a serious medical problem, get medical help right away.

Redness, swelling, or irritation at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop using this medication and tell your doctor right away if you have any serious side effects, including:

• new signs of a skin infection (heat, tenderness, pus)
• skin sores

Skin sores are more likely to develop when the medication is applied to skin folds (such as between the toes, beneath the breasts). Be careful to apply only a small amount to skin fold areas, and allow to dry completely before putting on shoes or clothing.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using gentian violet, tell your doctor or pharmacist if you are allergic to it; or to other dyes; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have a certain metabolic disease (porphyria), consult your doctor or pharmacist before using this product.

Tell your doctor if you are pregnant before using this medication.

It is unlikely that this product passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea, vomiting, diarrhea.

Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all medications and herbal products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.