Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for ketoconazole, the active ingredient registered with NAFDAC.
Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. …
Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. …
Ketoconazole shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
PRECAUTIONS Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of ketoconazole shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. INFORMATION FOR PATIENTS Patients should be advised of the following: Ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. …
PREGNANCY Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. …
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PKN Ketoconazole Cream contains Ketoconazole (2%), as cream, according to its NAFDAC registration record.
Yes. PKN Ketoconazole Cream is listed on the NAFDAC register under registration number A4-100696, and its registration is active as of 28 October 2026.
No WHO falsified or substandard medical product alert currently matches PKN Ketoconazole Cream in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-100696, 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.
Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not i (Summarised from the official U.S. FDA label for ketoconazole. Always follow your doctor or pharmacist.)
Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.