Medication

INDICATIONS AND USAGE BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION BenzaClin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups. Local Adverse Events - all causalities in >/= 1% of patients BenzaClin n = 420 Vehicle n = 168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Hypersensitivity/allergic reactions (including facial swelling and urticaria) have been reported in post-marketing use with BenzaClin Topical Gel . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark . Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 50 gram pump only, reassemble jar with pump dispenser. BenzaClin Topical Gel (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing. Store at room temperature up to 25°C (77°F) {See USP}. Do not freeze. Keep tightly closed. Keep out of the reach of children.