Aczone is an anti-infective medication.

Aczone is a topical gel used to help treat acne. The mechanism of action of in treating acne is not known. It is not for oral use. Use is contraindicated in persons with a hypersensitivity to dapsone.

Aczone gel may also be used for purposes not listed in this medication guide.

Contact your doctor immediately if you develop a rash while using Aczone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use Aczone gel exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Aczone gel is for use only on the skin. If this medicine gets in your eyes, mouth, or vagina, rinse with water.

Wash the skin before you apply Aczone gel. Gently pat dry with a clean towel. Also wash your hands after applying this medicine.

Use only a pea-sized amount of gel each time you apply this medicine.

Using benzoyl peroxide acne medication at the same time as Aczone may cause temporary changes in the color of your skin or facial hair.

Call your doctor if your symptoms do not improve after 12 weeks of treatment.

Store at room temperature away from moisture and heat. Do not freeze. Keep the tube tightly closed when not in use.

You should not use Aczone if you are allergic to dapsone.

To make sure Aczone gel is safe for you, tell your doctor if you have:

• glucose 6-phosphate dehydrogenase (G6PD) deficiency;

• a blood disorder called methemoglobinemia (abnormal red blood cells in your blood); or

• if you have ever had methemoglobinemia in the past.

It is not known whether Aczone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Dapsone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Aczone gel is not approved for use by anyone younger than 12 years old.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

An overdose of Aczone is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Rinse with water if this medicine gets in your eyes.

Avoid using other medications on the areas you treat with Aczone unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction to Aczone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Aczone may cause methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), a serious condition in which the amount of oxygen in your blood stream becomes dangerously low. Stop using this medicine and call your doctor at once if you notice a blue or gray appearance of your lips, fingernails, or the inside of your mouth.

Call your doctor at once if you have:

• severe sore throat;

• unusual thoughts or behavior;

• a red blood cell disorder - back pain, pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• pancreas problems - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Aczone side effects may include:

• dry or peeling skin;

• oily skin; or

• redness where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aczone can cause a serious condition called methemoglobinemia, especially if you use certain medicines at the same time, including sulfa drugs, acetaminophen (Tylenol), nitroglycerin or other nitrite heart medications, seizure medicine, and several other drugs. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Aczone gel.

This list is not complete. Other drugs may interact with dapsone topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.