SPL Set ID: 1cf11710-f966-4529-8e08-02175f588bca

Isotretinoin capsules, USP contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin, USP (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: sorbitan monooleate, soybean oil, stearoyl polyoxyglycerides, and vitamin E. The capsule shells contain the following: 10 mg - FD&C Blue No. 1, gelatin, and titanium dioxide 20 mg - FD&C Blue No. 1, gelatin, iron oxide yellow, and titanium dioxide 25 mg - D&C Yellow No. 10, FD&C Blue No. 1, FD&C Green No. 3, gelatin, and titanium dioxide 30 mg - FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide 35 mg - FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide 40 mg - FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide The black imprinting ink of the 10 mg and 20 mg capsules contain the following ingredients: ammonium hydroxide, iron oxide black, propylene glycol, and shellac. The black imprinting ink of the 25 mg and 35 mg capsules contain the following ingredients: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, iron oxide black, shellac and may contain propylene glycol. The black imprinting ink of the 30 mg and 40 mg capsules contain the following ingredients: iron oxide black, propylene glycol, shellac, and may contain ammonium hydroxide or potassium hydroxide and strong ammonia solution. Isotretinoin Chemically, isotretinoin, USP is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is: FDA approved dissolution test specifications differ from USP. 1