Dapsone is an anti-infective medication.

Dapsone topical (for the skin) is used to treat acne.

Dapsone topical may also be used for purposes not listed in this medication guide.

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.

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. Dapsone topical 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 dapsone. Gently pat dry with a clean towel. Also wash your hands after applying this medicine.

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

Using benzoyl peroxide acne medication at the same time as dapsone topical 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.

Usual Adult Dose for Acne:

Topical gel 5%: Apply approximately a pea-sized amount in a thin layer to the acne affected areas twice a day.
Topical gel 7.5%: Apply approximately a pea-sized amount in a thin layer to the entire face (and other affected areas) once a day.

Use: For the topical treatment of acne vulgaris

Usual Pediatric Dose for Acne:

12 years or older:
-Topical gel 5%: Apply approximately a pea-sized amount in a thin layer to the acne affected areas twice a day.
-Topical gel 7.5%: Apply approximately a pea-sized amount in a thin layer to the entire face (and other affected areas) once a day.

Use: For the topical treatment of acne vulgaris

You should not use dapsone topical if you are allergic to it.

To make sure dapsone topical 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 dapsone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Dapsone topical 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 dapsone topical 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze this medication.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Rinse with water if dapsone topical gets in your eyes.

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

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

Dapsone topical 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 dapsone topical and call your doctor at once if you notice a blue or gray appearance of your lips, fingernails, or the inside of your mouth.

Dapsone topical may cause serious side effects. 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 side effects of dapsone topical 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.

Dapsone topical 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 dapsone topical.

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.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.