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HSA Approval

NIZORAL CREAM 2%

SIN01117P

NIZORAL CREAM 2%

NIZORAL CREAM 2%

May 13, 1988

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence HolderJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore 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

Active Ingredients

KETOCONAZOLE

20 mg/g

Ketoconazole

Documents

Package Inserts

Nizoral Cream PI.pdf

Approved: May 9, 2023

Download

Patient Information Leaflets

Nizoral Cream PIL.pdf

Approved: May 9, 2023

Download

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