Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for isotretinoin, the active ingredient registered with NAFDAC.
Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. …
Clinical Trials and Postmarketing Surveillance The adverse reactions listed below reflect the experience from investigational studies of isotretinoin , and the postmarketing experience. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g. of the lips, nasal passage, and eyes). Dose Relationship Cheilitis and hypertriglyceridemia are usually dose related. …
Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity ).
Psychiatric Disorders Isotretinoin capsules may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric ). Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. …
Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS . Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS .
Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.
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Cosmin Gel## (null smpc) contains Isotretinoin (0.05%), as gel, according to its NAFDAC registration record.
Yes. Cosmin Gel## (null smpc) is listed on the NAFDAC register under registration number B4-6074, and its registration is active as of 5 November 2026.
No WHO falsified or substandard medical product alert currently matches Cosmin Gel## (null smpc) in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-6074, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin (Summarised from the official U.S. FDA label for isotretinoin. Always follow your doctor or pharmacist.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.