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HSA Approval

ZALAIN CREAM 2%

SIN10933P

ZALAIN CREAM 2%

ZALAIN CREAM 2%

May 17, 1999

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDCH AURIGA SINGAPORE
Licence HolderDCH AURIGA SINGAPORE

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Pharmacy Only
HSA Singapore Classification

Formulation Information

CREAM

**Dosage** Apply the cream one or two times every day (preferably at night or in the morning and at night), mildly and uniformly on the lesion, trying, besides, to embrace 1 cm of sound skin (approximately) around the affected area. The duration of the treatment to obtain the healing, varies from one patient to another, in function of the etiologic agent and location of the infection. In general, four weeks of treatment are recommended to ensure a complete clinical and microbiologic healing and the non appearance of relapses, though, in many cases, this clinical-microbiological healing appears earlier, between two and four weeks of treatment.

TOPICAL

Medical Information

**Indications** Topical treatment of surface skin mycoses, such as dermatophytosis, Tinea pedis (athlete's foot), Tinea cruris (Hebra's eczema), Tinea corporis (herpes circinatus), Tinea barbae (beard mycosis) and Tinea manus, Candidiasis (Moniliasis) and Pityriasis versicolor (Pityrosporum orbiculare, Malassezia furfur formerly).

**Contraindications** Are not known.

D01AC14

sertaconazole

Manufacturer Information

DCH AURIGA SINGAPORE

FERRER INTERNACIONAL SA

Active Ingredients

SERTACONAZOLE NITRATE

2%

Sertaconazole

Documents

Package Inserts

Zalain Cream PI.pdf

Approved: November 2, 2003

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