Benoxiclin1%+5%

• Mild to moderate acne vulgaris (inflammatory lesions) - patients 12 years and older

Adults and Adolescents (aged 12 years and older): Apply once daily in the evening to the entire affected area. Wash gently with a mild cleanser and fully dry before application. Apply a thin film and wash hands after application.

Children (under 12 years): Safety and efficacy have not been established; not recommended.

Very Common (≥1/10): Erythema, peeling, dryness (generally reported as 'mild' in severity)

Common (≥1/100 and <1/10): Burning sensation

Uncommon (≥1/1,000 and <1/100): Dermatitis, pruritus, erythematous rash, worsening of acne, paraesthesia

Not Known: Allergic reactions including hypersensitivity and anaphylaxis, colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain, urticaria, application site reactions (including skin discoloration)

• Avoid contact with mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin. In case of accidental contact, rinse well with water.
• Use with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
• Use with caution in atopic patients, in whom further skin drying may occur.
• During the first weeks of treatment, an increase in peeling and reddening will occur in most patients; use a non-comedogenic moisturiser or temporarily reduce frequency if needed.
• Benzoyl peroxide may cause increased sensitivity to sunlight; sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised.
• If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment should be discontinued immediately (may indicate antibiotic-associated colitis).