Acanya Gel

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INDICATIONS

ACANYA® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Important Limitations of Use

The safety and efficacy of the use of this product in the treatment of any other disorders have not been evaluated.

DOSAGE AND ADMINISTRATION

Apply a pea-sized amount of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) to the face once daily.

Use of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) beyond 12 weeks has not been evaluated. ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED

Dosage Forms And Strengths

Once admixed, ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) contains clindamycin phosphate 1.2% and benzoyl peroxide 2.5%, formulated as a topical gel. Each gram of ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide. ACANYA Gel is available in 50 gram jars.

ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is supplied as a kit containing the following components:

Components NDC # Net Weight
Benzoyl Peroxide Gel NDC 59987-101-25 40g
Clindamycin Phosphate Solution NDC 59987-101-24 10g

Admixing Instructions

  • Prior to dispensing, add the clindamycin phosphate solution in the bottle to the benzoyl peroxide gel and stir with the provided spatula until homogenous (at least 1 ½ minutes).
  • ACANYA Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) (admixed) can be stored at room temperature up to 25°C (77°F) for 2 months.
  • Place a 2 month expiration date on the label immediately following admixing.

Storage and Handling

  • Store at 25°C (77°F).
  • Protect from freezing.
  • Keep out of the reach of children.
  • Keep jar tightly closed.

Issued 6/2010. Marketed by: Coria Laboratories, a division of Valeant Pharmaceuticals North America, Fort Worth, TX 76107. Manufactured by: Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213.

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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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