Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

Solaraze® Gel is applied to lesion areas twice daily. It is to be smoothed onto the affected skin gently. The amount needed depends upon the size of the lesion site. Assure that enough Solaraze® Gel is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site. The recommended duration of thera-py is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered.

Available in tubes of 50 g (NDC 10337-803-05) and 100 g (NDC 10337-803-01). Each gram of gel contains 30 mg of diclofenac sodium.

Storage: Store at controlled room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Protect from heat. Avoid freezing.

Manufactured by Patheon Inc., Toronto, Ontario, Canada.
Manufactured for: DOAK DERMATOLOGICS., A SUBSIDIARY OF BRADLEY PHARMACEUTICALS, INC., 383 Route 46 West • Fairfield, NJ 07004, USA
www.doakderm.com
FDA rev date: 6/1/2007

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