Aczone Gel

INDICATIONS

ACZONE Gel (dapsone) , 5%, is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION

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 (dapsone) , 5%, in a thin layer to the acne affected areas twice daily. Rub in ACZONE Gel (dapsone) , 5%, gently and completely. ACZONE Gel (dapsone) , 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE Gel (dapsone) , 5%.

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

HOW SUPPLIED

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 15-30C (59-86F). 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

Last reviewed on RxList: 3/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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