Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CREAM
**DOSAGE AND ADMINISTRATION** For external use only. Apply sparingly, a thin film over the affected skin areas two to four times daily. Reduce the frequency of application gradually as improvement occurs and eventually discontinue.
TOPICAL
Medical Information
**INDICATIONS** Hydrocortisone is a mild corticosteroid indicated for irritant contact dermatitis, allergic contact dermatitis and insect bites. Irritant dermatitis may be caused by common household products such as detergents, bleaches, washing powders and various chemicals found in the workplace. Allergic contact dermatitis is caused by sensitisation to allergens in materials such as cosmetics, resins, rubber, adhesive plaster and plants. It may also be helpful in treating napkin rash if used under medical supervision.
**CONTRAINDICATIONS** It should not be used for untreated viral skin infections eg. herpes simplex (cold sores) and chicken pox; fungal infections eg. candidiasis; bacterial infections; in rosacea and ulcerative conditions; and in patients with a history of sensitivity to any of its components.
D07AA02
hydrocortisone
Manufacturer Information
APEX PHARMA MARKETING PTE. LTD.
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
Active Ingredients
Documents
Package Inserts
Proposed Hydrocortisone Cream_PI (Clean Copy).pdf
Approved: April 19, 2022