Oratane Description

Isotretinoin (BP.Ph.Eur) 5 mg, 10 mg and 20 mg Capsules.
Isotretinoin is a retinoid with a specific antiseborrheic action for oral treatment of severe cystic acne and conglobate acne resistant to other forms of treatment.
Isotretinoin, the active ingredient of ORATANE, is a synthetic stereoisomer of all-trans retinoic acid (tretinoin), an active substance that has proved effective in topical treatment of acne vulgaris. Isotretinoin is chemically identified as 13-cis retinoic acid: (2Z, 4E, 6E, 8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid, molecular weight 300.42 and molecular formula is C₂₀H₂₈O₂.
Excipients/Inactive Ingredients: The 5 mg, 10 mg and 20 mg capsules contain the following excipients: sodium edetate, soya oil (refined), beeswax (yellow), butylated hydroxyanisole, dl-α-tocopherol, soya bean oil hydrogenated, partly hydrogenated soya oil, gelatin, glycerol, sorbitol, and titanium dioxide. In addition the 10 mg capsules contain Ponceau Red (CI 16255) and ferric oxide (black). The 20 mg capsules contain Ponceau Red (CI 16255) and indigo carmine (CI730150).