SPL Set ID: b44200ba-6672-4ea7-b151-7caec3f53c9c

Isotretinoin capsules, USP Isotretinoin capsules, USP contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems: 10 mg – iron oxide (yellow) and titanium dioxide; 20 mg – iron oxide (red), and titanium dioxide; 25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14) ] , FD&C Yellow #6 and titanium dioxide; 30 mg – iron oxide (black, red and yellow) and titanium dioxide; 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide; 40 mg – iron oxide (black, red and yellow) and titanium dioxide. Isotretinoin Chemically, isotretinoin 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: Isotretinoin capsules, USP meets USP Dissolution Test 3. Structure