Aclene Plus Gel

Aclene Plus gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.

Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.

Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.

Should not be administered to individuals who are hypersensitive to any of its component.

Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.

There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.

Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.

Topical retinoid and related preparations

Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.