MedPath
HSA Approval

CUTIVATE CREAM 0.05% w/w

SIN08628P

CUTIVATE CREAM 0.05% w/w

CUTIVATE CREAM 0.05% w/w

March 26, 1996

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

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

Formulation Information

CREAM

**Dosage and Administration** Pharmaceutical form: Cream For eczema/dermatitis, apply a thin film of _CUTIVATE_ Cream to the affected skin areas once daily. For all other indications, apply a thin film of _CUTIVATE_ Cream to the affected skin areas twice daily. Calculation of the appropriate dosage for children should allow for their greater surface area to body weight ratio.

TOPICAL

Medical Information

**Indications** **TREATMENT OF INFLAMMATORY DERMATOSES** _CUTIVATE_ Cream is indicated for adults and children for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as: - Eczema including atopic, infantile, and discoid eczemas - Prurigo nodularis - Psoriasis (excluding widespread plaque psoriasis) - Neurodermatoses including lichen simplex - Lichen planus - Seborrhoeic dermatitis - Contact sensitivity reactions - Discoid lupus erythematosus - An adjunct to systemic steroid therapy in generalised erythroderma - Insect bite reactions - Prickly heat

**Contraindications** The following conditions should not be treated with _CUTIVATE_ Cream: - Rosacea - Acne vulgaris - Perioral dermatitis - Primary cutaneous viral infections (e.g. herpes simplex, chickenpox) - Hypersensitivity to any of the ingredients - Perianal and genital pruritus - Pruritus without inflammation - The use of _CUTIVATE_ Cream is not indicated in the treatment of primary infected skin lesions caused by infection with fungi or bacteria. - Dermatoses in children under one year of age, including dermatitis and napkin rash.

D07AC17

fluticasone

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)

Active Ingredients

FLUTICASONE PROPIONATE

0.05% w/w

Documents

Package Inserts

Cutivate Cream PI.pdf

Approved: October 26, 2020

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

CUTIVATE CREAM 0.05% w/w - HSA Approval | MedPath