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HSA Approval

SKINOREN CREAM 20%

SIN07138P

SKINOREN CREAM 20%

SKINOREN CREAM 20%

July 14, 1992

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 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

AZELAIC ACID

20g/100g

Azelaic acid

Documents

Package Inserts

063332-XX_2.pdf

Approved: September 27, 2019

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SKINOREN CREAM 20% - HSA Approval | MedPath