Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CREAM
**Dosage and administration** **Cutaneous use** Skinoren cream should be applied to the affected areas of skin twice a day (morning and evening) and rubbed in gently. The amount of Skinoren cream to be applied will depend on the size of the affected area. As a guide, a daily dose of approximately 2.5cm/1inch of cream is sufficient for the entire facial area. Before Skinoren cream is applied, the skin should be thoroughly cleaned with clear water, or if applicable, a mild skin-cleansing agent. It is important to continue to use Skinoren cream regularly over the entire period of treatment. The duration of use of Skinoren cream can vary from patient to patient and also depends on the severity of the acne. In patients with acne, in general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, however, Skinoren should be used regularly over several months. However, Skinoren should not be used continuously for more than 12 months at any time. In the event of excessive irritation of the skin (see “Side effects” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), the amount of cream per application should be reduced or the frequency of use of Skinoren cream should be reduced to once a day until the irritation ceases, or the treatment should be temporarily interrupted for a few days. **Pediatric population** Dose adjustment is not required when Skinoren cream is administered to adolescents aged 12–18 years of age. The safety and efficacy of Skinoren cream in children below the age of 12 years have not been established.
TOPICAL
Medical Information
**Indications** Treatment of acne vulgaris.
**Contraindications** Hypersensitivity to the active substance or to any of the excipients of the cream, in particular propylene glycol.
D10AX03
azelaic acid
Manufacturer Information
DKSH SINGAPORE PTE. LTD.
LEO Pharma Manufacturing Italy S.r.I.
Active Ingredients
Documents
Package Inserts
063332-XX_2.pdf
Approved: September 27, 2019