Benzoyl Peroxide

1 INDICATIONS AND USAGE EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Before initial use, prime the pump until the first drop of cream is released. Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin. Avoid the eyes, lips and mouth. Wash hands after application. EPSOLAY may bleach hair or colored fabric. EPSOLAY is for topical use only. Not for oral, ophthalmic, or intravaginal use. Discard unused EPSOLAY 60 days after first use. Apply to the affected areas once daily. ( 2 ) Wash hands after application. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years. Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle * Application site edema includes: application site swelling and application site edema EPSOLAY N=488 Vehicle N=234 Application site pain 11 (2%) 2 (1%) Application site erythema 11 (2%) 2 (1%) Application site pruritus 6 (1%) 1 (<1%) Application site edema* 4 (1%) 0 (0%) During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning. Table 2 presents the local tolerability assessments by severity grade at Week 12. Table 2: Facial Cutaneous Tolerability Assessment * Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12. Sign/Symptom EPSOLAY N=455* Severity at Week 12 Mild Moderate Severe Dryness 25% 7% 0% Itching 24% 6% 0% Scaling 13% 4% 0% Stinging/Burning 20% 3% 1% In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

12.3 Pharmacokinetics Benzoyl peroxide is absorbed by the skin where it is converted to benzoic acid, an endogenous substance, which is eliminated in the urine. The systemic exposure of benzoyl peroxide following the application of EPSOLAY was not assessed.