Acanya (Benzoyl Peroxide / Clindamycin Phosphate) - Indications and Dosage

INDICATIONS AND USAGE

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 to the face once daily.

Use of ACANYA Gel beyond 12 weeks has not been evaluated. ACANYA Gel is not for oral, ophthalmic, or intravaginal use.

DOSAGE FORMS AND STRENGTHS

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

HOW SUPPLIED, ADMIXING INSTRUCTIONS AND STORAGE AND HANDLING

How Supplied

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 (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.