Skin disinfection. It also performs antiseptic activity against P. acnes.
Dosage and method of use
BENZAC 5% gel is BENZAC 10% gel: Apply Benzac locally on the skin favoring its penetration with a light massage. Applications must take place once or twice a day, as needed, spreading a small amount of Benzac with the fingertips on the affected parts, previously thoroughly cleaned with a mild detergent and carefully dried, massaging lightly until absorbed. People with sensitive skin should apply the gel once a day or once every two days before going to bed. BENZAC CLEAN 5% gel: Apply the gel once or twice a day on the affected area. Moisten the application area. Bring the required amount of BENZAC CLEAN 5% gel on the fingertips and spread it on the various parts of the skin in a circular motion, as if washing. Skin contact time should be as short as possible (1 to 5 minutes) to minimize the risk of undesirable effects (see section 4.8). Rinse thoroughly with water and dry.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Adverse reactions from clinical trials all relate to skin disorders. They are reversible if treatment is reduced in frequency or stopped. The frequency of adverse reactions is divided into the following categories: Very common (≥1 / 10) Common (≥1 / 100,
|Skin and subcutaneous tissue disorders|
|erythema, skin exfoliation (peeling), skin burning sensation, dry skin|
|skin irritation (irritative contact dermatitis), itching, skin pain (pain, stinging)|
|allergic contact dermatitis|
Cases of facial swelling and allergic reactions, including application site hypersensitivity and anaphylaxis (with frequency unknown) have been reported from post-marketing pharmacovigilance data. Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Benzac is for external use only. The use, especially if prolonged, of products for cutaneous use can give rise to sensitization phenomena; in this case, stop the treatment and consult your doctor to establish a suitable therapy. Probably, at the first application, a slight burning sensation may be felt and, within a few days, a slight redness and peeling of the skin may occur. During the first few weeks of treatment, a sudden increase in desquamation occurs in most patients. This is not dangerous and usually regresses within a day or two if treatment is temporarily stopped. Patients should be directed to use the drug less frequently, to temporarily stop or discontinue use, in case of severe irritation. Benzoyl peroxide can cause swelling and blistering of the skin; if any of these symptoms occur, the medicine should be discontinued. Avoid contact with the eyes, mouth, corners of the nose and other mucous membranes. If the medicine gets into the eye, wash it off with plenty of water. Caution should be exercised when applying the medicine to the neck and other sensitive areas. The oxidative action of the gel can discolour dyed hair and colored clothing. Do not apply to abraded or irritated skin. Avoid exposure to the sun and ultraviolet rays when applying benzoyl peroxide. Pediatric population: No efficacy and safety data are available in children below 12 years.
Pregnancy and breastfeeding
Fertility, pregnancy: There is no safety concern with the effects of benzoyl peroxide applied to the skin on reproductive function, fertility, teratogenicity, or peri- and postnatal development in animals. The generalized clinical use for the cutaneous treatment of acne vulgaris, for several decades, at concentrations up to 10% w / w of benzoyl peroxide has never been associated with such effects. In any case, the drug should be administered in cases of actual need under the direct supervision of the doctor. Lactation: It is not known whether benzoyl peroxide is excreted in animal or human milk. Since many drugs are excreted in breast milk, caution should be exercised when benzoyl peroxide contained in gel is used by breastfeeding women. The preparation should not be applied to the breast to avoid accidental transfer to the infant.
Expiration and retention
BENZAC 5% gel, BENZAC 10% gel and BENZAC CLEAN 5% gel: do not store above 25 ° C
Interactions with other drugs
Avoid the simultaneous use of strong detergents, alcoholic products, acne skin preparations and medicines used in the treatment of acne containing substances that can increase the effect peeling, irritants or causing dry skin, such as those based on tretinoin, resorcinol, salicylic acid and sulphides, medicated cosmetics.
Benzac is for cutaneous use only. Excessive application of the product does not lead to faster or better results but can lead to irritation. If severe irritation develops, treatment should be discontinued and appropriate symptomatic therapy instituted.
100 g of gel contain:
|Active principle:||BENZAC 10% gel||BENZAC 5% gel|
|Benzoyl peroxide||10 g||5 g|
Excipient with known effect: Propylene glycol For a full list of excipients, see section 6.1 100 g of gel contain:
|Active principle||BENZAC CLEAN 5% gel|
|Benzoyl peroxide||5 g|
For the full list of excipients, see section 6.1
BENZAC 5% gel and BENZAC 10% gel Carbomer 940, Methacrylic copolymer, Glycerin, Disodium Edetate, Dioctyl sodium sulfosuccinate, Colloidal silica, Propylene glycol, Poloxamer 182, Demineralized water. BENZAC CLEAN 5% gel Acril Copolymer, Carbomer 940, Sodium C14 – C16 Olefin Sulfonate, Glycerol, Sodium Hydroxide, Demineralized water.