August 29, 2016
Recommended Topic Related To:

Aczone Gel

"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.



Aczone Gel

How Supplied


ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris.


For topical use only. Not for oral, ophthalmic, or intravaginal use.

After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE® Gel, 5%, in a thin layer to the acne affected areas twice daily. Rub in ACZONE® Gel, 5%, gently and completely. ACZONE® Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE® Gel, 5%.

If there is no improvement after 12 weeks, treatment with ACZONE® Gel, 5%, should be reassessed.


Dosage Forms And Strengths

Gel, 5%. Each gram of ACZONE® gel contains 50 mg of dapsone in a white to pale yellow gel.

Storage And Handling

ACZONE® (dapsone) Gel, 5%, is supplied in the following size tubes:

NDC 0023-3670-30
30 gram laminate tube

NDC 0023-3670-60
60 gram laminate tube

NDC 0023-3670-90
90 gram laminate tube

Store ACZONE® gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F). Protect from freezing.

Allergan, Inc., Irvine, CA 92612, U.S.A. Revised: July 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/4/2016

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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