Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
GEL
**4.2. Posology and method of administration** Epiduo should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether. The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. The safety and effectiveness of Epiduo have not been studied in children below 9 years of age.
TOPICAL
Medical Information
**4.1. Therapeutic indications** Cutaneous treatment of _Acne vulgaris_ when comedones, papules and pustules are present (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**4.3. Contraindications** Pregnancy (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Women planning a pregnancy. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
D10AD53
adapalene, combinations
Manufacturer Information
GALDERMA SINGAPORE PRIVATE LIMITED
LABORATOIRES GALDERMA
Active Ingredients
Documents
Package Inserts
Epiduo Gel PI.pdf
Approved: October 29, 2019