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

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

• Professional Sample: 3 gram laminate tube
• Commercially: 30 gram laminate tube

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

Professional Sample

5 % NDC XXXX-XXXX-XX...................Product Code 500503
3 gram laminate tube

Commercially Available as:

5 % NDC XXXX-XXXX-XX........................Product Code 500530
30 gram laminate tube

KEEP OUT OF THE REACH OF CHILDREN LESS THAN 12 YEARS OLD.

Storage conditions:

Store at controlled room temperature, 20-25°C (68-76°F), excursions permitted to 15-30ºC (59-86ºF). Protect from freezing.

ACZONE™ (dapsone) Gel, 5% Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for QLT, USA, Inc., Fort Collins, CO 80525. FDA Rev date: 3/14/2008

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