SPL Set ID: ec1bb0d1-f38a-4080-831a-68791d1d1fdb
1 drug(s) with this SPL Set ID
ZORYVE (roflumilast) cream is a white to off-white cream for topical use. The active ingredient, roflumilast, is a phosphodiesterase 4 (PDE4) inhibitor. Roflumilast is described chemically as 3-cyclopropylmethoxy- N -(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide. The empirical formula is C 17 H 14 Cl 2 F 2 N 2 O 3, and the molecular weight is 403.21. The structural formula is represented below: Roflumilast is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Each gram of cream, 0.05%, 0.15%, or 0.3%, contains 0.5 mg, 1.5 mg, or 3 mg of roflumilast, respectively, in a cream base containing ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methylparaben, propylparaben, purified water, sodium hydroxide, and white petrolatum. Hydrochloric acid may have been added to adjust pH. Chemical Structure