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HSA Approval

DERMOVATE OINTMENT 0.05% w/w

SIN04933P

DERMOVATE OINTMENT 0.05% w/w

DERMOVATE OINTMENT 0.05% w/w

July 12, 1990

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

OINTMENT

**Dosage and Administration** Pharmaceutical form: Cream and Ointment Apply sparingly to the affected area once or twice daily. Therapy should be discontinued when control is achieved. Treatment should not be continued for more than four weeks without the patient’s condition being reviewed. Repeated short courses of _DERMOVATE_ may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used. In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of _DERMOVATE_ can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion. **Children** _DERMOVATE_ is contraindicated in children under one year of age. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Care should be taken when using _DERMOVATE_ to ensure the amount applied is the minimum that provides therapeutic benefit. **Elderly** The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit. **Renal/Hepatic Impairment** In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

TOPICAL

Medical Information

**Indications** - Psoriasis (excluding widespread plaque psoriasis) - Recalcitrant eczemas - Lichen planus - Discoid lupus erythematosus - Other skin conditions which do not respond satisfactorily to less potent steroids

**Contraindications** The following conditions should not be treated with _DERMOVATE_ - Hypersensitivity to clobetasol, or to any of the excipients in the preparation - Primary skin lesions caused by infection with fungi or bacteria - Primary cutaneous viral infections (e.g. herpes simplex, chickenpox) - Rosacea - Acne vulgaris - Pruritus without inflammation - Perianal and genital pruritus - Perioral dermatitis _DERMOVATE_ is contraindicated in dermatoses in children under one year of age, including dermatitis.

D07AD01

clobetasol

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXO WELLCOME OPERATIONS

Delpharm Poznan S.A.

Active Ingredients

CLOBETASOL PROPIONATE

0.05% w/w

Clobetasol propionate

Documents

Package Inserts

Dermovate_PI.pdf

Approved: March 21, 2023

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