Validerm

VALIDERM® is comprised of 0.2 mg of Calcitriol USP, 50 mg of Fluticasone Propionate USP, and 50 mg of Tacrolimus USP for dermatological use.1 VALIDERM® also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Calcitriol, Fluticasone Propionate and Tacrolimus comparable to the active ingredients (Vectical® 3mcg/g, Cutivate® 0.05%, and Protopic® 0.1%) contained in VALIDERM®. 2

1

Certificate of analysis on file

2

This product is not manufactured by Galderma Labs LP, manufacturer of Vectical®, GlaxoSmithKline, manufacturer of Cutivate®, or by Astellas Pharma US, Inc., manufacturer of Protopic®.