BENZAC AC Gel

For the topical treatment of acne vulgaris.

Recommended dose

Apply once or twice daily to cover affected areas after washing with a mild cleanser and water.

For external use only.

Pediatric use: Safety and effectiveness in children have not been established.

In patients with history of hyper-sensitivity to any their components.

Skin and subcutaneous tissue disorders:

・Very common: Dry skin, Erythema, Skin exfoliation (peeling), Skin burning sensation.

・Common: Pruritus, Pain of skin (pain, stinging), Skin irritation (irritant contact dermatitis).

・Uncommon: Allergic contact dermatitis.

Swelling face (unknown frequency) has been reported during post-marketing surveillance.

There is no known interaction with other medications which might be used cutaneously and concurrently with benzoyl peroxide gel or lotion; however, drugs with Desquamative, irritant ad drying effects should not be used concurrently with benzoyl peroxide gel or lotion.

See the package insert about the details.

Pregnancy

Benzoyl peroxide should be used only if clearly needed.

Lactation

Caution should be exercised when benzoyl peroxide is administered to a nursing woman and the preparation should not be applied on the chest to avoid accidental transfer to the infant.

If severe irritation develops, discontinue use and institute appropriate therapy.

After the reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

A mild burning sensation will probably be felt on first application and some reddening and peeling of the skin will occur within a few days. During the first weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is temporarily discontinued. If severe irritation occurs, patients should be directed to use the medication less frequently, to temporarily discontinue use or to discontinue use altogether.

Avoid contact with eyes, eyelids, mouths and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration.

If excessive irritation develops, discontinue use and consult your physician.

May contain benzoic acid as a degradation product of benzoyl peroxide.

Repeated exposure to sunlight or UV radiation should be avoided.

Due to the risk of sensitization, benzoyl peroxide gel or lotion should not be applied on damaged skin.

Carcinogenesis, mutagenesis, impairment of fertility: See the package insert about the details.

The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids and mild desquamation (drying and peeling activity) with a simultaneous reduction in comedones and acne lesions.