Ketoral Ketoconazole Cream 2%, 30g

Product Name & Strength: Ketoral Cream, Ketoconazole 20 mg/g, 30 g.

Indications (Approved Uses): Indicated for the treatment of mycotic infections of the skin, specifically tinea pedis (athlete's foot), tinea cruris (dhobie itch), and candidal intertrigo (sweat rash). It provides potent antimycotic action against dermatophytes and yeasts, rapidly relieving pruritus associated with these infections.

Contraindications (Safety Warnings): Contraindicated in individuals with a known hypersensitivity to the active substance or to any of the excipients. It is strictly not for ophthalmic use. To prevent a rebound effect when stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid in the morning and apply ketoconazole cream in the evening, gradually withdrawing the steroid therapy over a period of 2 to 3 weeks.

Side Effects (Adverse Reactions): Common adverse reactions include application site pruritus, skin burning sensation, and application site erythema. Uncommon side effects may include bullous eruption, contact dermatitis, rash, skin exfoliation, sticky skin, and various application site conditions (bleeding, discomfort, dryness, inflammation, irritation, paraesthesia, or general reaction). Excessive topical application may lead to erythema, oedema, and a burning sensation, which will disappear upon discontinuation of treatment.

Nutritional Information (per 1 g): Ketoconazole USP 20 mg, white soft paraffin, cetostearyl alcohol, cetomacrogol-1000, light liquid paraffin, chlorocresol, propylene glycol, propyl paraben, purified water.

Instructions for Use / Dosage: For topical administration. For use in adults. For tinea pedis, apply to the affected areas twice daily; the usual duration for mild infections is 1 week, whilst more severe or extensive infections should be treated for 2 to 3 days after all signs of infection have disappeared to prevent relapse. For tinea cruris and candidal intertrigo, apply to the affected areas once or twice daily until 2 to 3 days after all signs of infection have disappeared. Treatment for up to 6 weeks may be necessary. If no improvement in symptoms is experienced after 4 weeks of treatment, a doctor should be consulted.

Regulatory Information: NAFDAC Registration Number: B4-1177. Manufactured by: Yash Medicare Pvt. Ltd, India.