1. Patients should use ACZONE® Gel, 5%, as directed by the physician. ACZONE® Gel,
5%, is for external topical use only. ACZONE® Gel, 5%, is not for oral, ophthalmic or intravaginal
2. Patients should not use this medication for any disorder other than that for which it was prescribed.
3. Patients should tell their physician if they have any history of anemia or an enzyme deficiency (such as G6PD
4. Patients should be informed as to the need for laboratory evaluation prior to starting ACZONE®
5. Patients should report any signs of adverse reactions to their physician.
6. Protect ACZONE® Gel, 5%, from freezing and light. Return to the original carton after
application to protect from light.
ACZONE® (dapsone) Gel 5%
Read this important information before you start using ACZONE® (AK-zon) Gel and each time you
refill your prescription. There may be new information that you need to know. This summary is not meant to take the
place of your doctorís advice. If you have any questions or want more information about ACZONE®
Gel, ask your doctor or pharmacist.
What is ACZONE® Gel?
ACZONE® Gel is a prescription skin use (topical) medicine used to help treat acne in people 12
years and older.
ACZONE® Gel has not been studied in children under 12 years of age.
Who should not use ACZONE® Gel?
Do not use ACZONE® Gel if you are allergic any of the ingredients in ACZONE® Gel.
Ask your doctor or pharmacist for a list of these ingredients. The active ingredient is dapsone. See the end of this
leaflet for a complete list of ingredients in ACZONE® Gel.
What should I tell my doctor before using ACZONE® Gel?
Tell your doctor about all of your medical conditions, including if you:
· are pregnant or planning to become pregnant. It is not known if ACZONE
Gel may harm your unborn baby.
· are breastfeeding. ACZONE®Gel passes into your milk and
may harm your baby. You should choose either to use ACZONE® Gel, or breastfeed, but not both. Talk to
you doctor about the best way to feed your baby while using ACZONE® Gel.
· have a history of anemia or have been diagnosed with glucose-6-phosphate
Tell your doctor about all the medicines you are taking including prescription and nonprescription
medicines, vitamins and herbal supplements. Especially, tell your doctor if you are using any other medicines
applied to the skin.
How do I use ACZONE® Gel?
· Use ACZONE® Gel exactly as prescribed by your doctor.
ACZONE® Gel is usually used on your affected skin twice a day, once in the morning and once in the
· Wash the areas of your skin where you will apply ACZONE®
Gel. Gently pat your skin dry with a clean towel.
· Apply a thin layer of ACZONE® Gel to the areas of your
skin that have acne. A pea- sized amount of ACZONE® Gel will usually be enough.
· Rub the medicine in gently and completely
· Make sure to put the cap back on the ACZONE® Gel tube.
Close it tightly and put the tube back in its original box.
· Wash your hands after applying ACZONE® Gel.
· Keep ACZONE® Gel away from your mouth and eyes. Do not
swallow ACZONE® Gel. If you swallow ACZONE® Gel, call your doctor or poison control
center right away.
· If your acne does not get better after using ACZONE® for
12 weeks, talk to your doctor about other treatments for acne.
What are the possible side effects of ACZONE® Gel?
Like all medicines, ACZONE® Gel can cause some side effects. These side effects are usually mild.
The most common side effects of ACZONE® Gel are dryness, redness, oiliness and peeling of the skin
Call your doctor if you have excessive tiredness or any side effects that do not go away or bother you. This is
not a complete list of all the side effects. If you have any questions, ask your doctor or pharmacist.
How should I store ACZONE® Gel?
Store ACZONE® Gel at room temperature 68 to 76 ºF. Do not freeze ACZONE® Gel.
Protect ACZONE® Gel tube from light. Store in original box after using it.
Keep ACZONE® Gel out of the reach of children less than 12 years of age.
Where can I find more information about ACZONE® Gel?
If you have any questions or want more information about ACZONE® Gel, ask your doctor or
pharmacist. Your doctor or pharmacist can also give you a copy of the ACZONE® Gel Package Insert
written for health professionals. Ask them to explain anything you do not understand.
You may call 1-800-727-7003 to obtain more information about ACZONE® Gel.