Regulatory Information
GALDERMA SINGAPORE PRIVATE LIMITED
GALDERMA SINGAPORE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
GEL
**DOSAGE AND ADMINISTRATION** **Recommended Dose and Dosage Adjustment** EPIDUO FORTE Gel (adapalene 0.3%/benzoyl peroxide 2.5%) Gel (patients 12 years of age and older), should be applied to affected areas of the face, chest and back once daily in the evening, after washing gently with a non-medicated cleanser. A small amount of EPIDUO FORTE Gel should be applied to provide a thin film, avoiding eyes, lips and mucous membranes. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers. Discontinue treatment if a severe local inflammatory response is experienced. Reinstitute therapy when the reaction has subsided, initially applying the preparation less frequently (e.g. every other day). Once-daily application may be resumed if it is judged that the patient is able to tolerate the treatment. **Missed Dose** If a single dose is missed, dosing should continue as per usual the following day, and the usual amount should be applied.
TOPICAL
Medical Information
**INDICATIONS AND CLINICAL USE** EPIDUO FORTE Gel (adapalene 0.3%/benzoyl peroxide 2.5%) is indicated for: - Treatment of acne vulgaris, characterized by comedones, inflammatory papules/pustules with or without occasional nodules in patients 12 years of age and older. (See Clinical Trials Section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
**CONTRAINDICATIONS** - Patients who are hypersensitive to adapalene, benzoyl peroxide or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Application to areas of skin affected by eczema or seborrhoeic dermatitis - Pregnancy - Women planning a pregnancy
D10AD53
adapalene, combinations
Manufacturer Information
GALDERMA SINGAPORE PRIVATE LIMITED
G PRODUCTION INC
Laboratoires Galderma
Active Ingredients
Documents
Package Inserts
Epiduo Forte PI.pdf
Approved: May 22, 2021