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HSA Approval

FUCICORT CREAM

SIN00723P

FUCICORT CREAM

FUCICORT CREAM

May 3, 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

**Dosage** Uncovered lesions: 2–3 daily applications. Covered lesions: Less frequent application may be adequate.

TOPICAL

Medical Information

**Indications** Fucicort® is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur. Inflammatory dermatoses include atopic eczema, discoid eczema, stasis eczema, seborrhoeic, dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus.

**Contra-indications** Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the Excipients. Due to the content of corticosteroid, Fucicort® is contraindicated in the following conditions: Systemic fungal infections Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see Special Warnings and Precautions for Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy. Perioral dermatitis and rosacea

D07CC01

betamethasone and antibiotics

Manufacturer Information

DKSH SINGAPORE PTE. LTD.

LEO Pharma A/S

LEO LABORATORIES LIMITED

Active Ingredients

BETAMETHASONE VALERATE EQV BETAMETHASONE

1 mg/g

Betamethasone

FUSIDIC ACID

20 mg/g

Fusidic acid

Documents

Package Inserts

Fucicort Cream_PI.pdf

Approved: October 9, 2019

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FUCICORT CREAM - HSA Approval | MedPath