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HSA Approval

FUCIDIN CREAM 2%

SIN01547P

FUCIDIN CREAM 2%

FUCIDIN CREAM 2%

May 27, 1988

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDKSH SINGAPORE PTE. LTD.
Licence HolderDKSH SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

CREAM

**Application** Fucidin® cream is applied to the affected area 2–3 times daily, generally for a period of 7 days, except in treatment of acne where therapy should be extended for a longer period according to the nature of this disease.

TOPICAL

Medical Information

**Indications** Fucidin® cream is indicated for treatment of skin infections caused by staphylococci, streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. The most important indications being: ImpetigoBoilsCarbunclesParonychiaInfected woundsSycosis barbaeHidradenitisErythrasmaFolliculitis Fucidin® cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections.

**Contraindications** Hypersensitivity to the active substance or to any of the excipients.

D06AX01

fusidic acid

Manufacturer Information

DKSH SINGAPORE PTE. LTD.

LEO LABORATORIES LIMITED

Active Ingredients

FUSIDIC ACID

20 mg/g

Fusidic acid

Documents

Package Inserts

Proposed Clean PI- Fucidin Cr 2%.docx

Approved: April 7, 2017

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