Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CREAM
**Dosage and Administration** **Dosage** Cutaneous candidosis, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pityriasis) versicolor: it is recommended that NIZORAL® 2% Cream be applied once daily to cover the affected and immediate surrounding area. Seborrheic dermatitis: NIZORAL® 2% Cream should be applied to the affected area once or twice daily. The usual duration of treatment is tinea versicolor 2–3 weeks, yeast infections 2–3 weeks, tinea cruris 2–4 weeks, tinea corporis 3–4 weeks, tinea pedis 4–6 weeks. The usual initial duration of treatment in seborrheic dermatitis is 2 to 4 weeks. Maintenance therapy is applied once or twice weekly in seborrheic dermatitis. Treatment should be continued, until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment. **Special populations** **_Pediatrics_** There are limited data on the use of ketoconazole 2% cream in pediatric patients. **Administration** Topical administration to the skin.
TOPICAL
Medical Information
**Indications** NIZORAL® 2% Cream is indicated for topical application in the treatment of dermatophyte infections of the skin: tinea corporis, tinea cruris, tinea manus and tinea pedis due to _Trichophyton rubrum_, _Trichophyton mentagrophytes_, _Microsporum canis_ and _Epidermophyton floccosum_, as well as in the treatment of cutaneous candidosis and tinea (pityriasis) versicolor. NIZORAL® 2% Cream is also indicated for the treatment of seborrheic dermatitis, a skin condition associated with the presence of _Malassezia furfur_.
**Contraindications** NIZORAL® 2% Cream is contraindicated in individuals with a known hypersensitivity to any of its ingredients.
D01AC08
ketoconazole
Manufacturer Information
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
JANSSEN PHARMACEUTICA NV