Properties
What is it?
International Nonproprietary Name - Benzoyl Peroxide Composition: Benzoyl peroxide aqueous, equivalent to 5% w-w anhydrous benzoyl peroxide. List of excipients: Carbomer 934; Polysorbate 80 (Tween 80); Methylparaben; Sodium hydroxide; Otto Rose oil; Purified water. Indications: Used topically for the treatment of acne (acne vulgaris). Contraindications: Hypersensitivity to the active substance or any of the excipients. Dosage and method of administration: For external use only. Adults and children: The skin should be cleansed and dried before each application. Apply a thin layer once or twice daily or as directed by a physician to the affected area. For individuals with sensitive skin, it is recommended to use the gel once daily, before bedtime. The degree of dryness or peeling can be adjusted by changing the dosage regimen. Fertility, pregnancy and lactation: Pregnancy: Benzoyl peroxide is used in pregnant women only when strictly necessary. Lactation: It is not known whether benzoyl peroxide or its metabolites are excreted in breast milk. The risk to newborns or breastfed infants cannot be excluded; therefore, to avoid contact between the infant and benzoyl peroxide, the product should not be applied to the breast area. Effects on ability to drive and use machines: Benzoyl has no or negligible effect on the ability to drive and use machines. Possible side effects: Skin dryness; erythema; skin exfoliation (peeling); skin burning sensation; itching; skin pain (pain, irritation), skin irritation (irritant contact dermatitis). Reporting of side effects: It is very important to collect information on adverse reactions to the medicinal product. This allows for an ongoing assessment of the benefit-risk balance of the medicinal product. In the event of any adverse reaction, the treating physician or pharmacist should be informed. Overdose: Benzoyl peroxide gel is intended for topical use only. Overuse of the product will not result in faster or better results, but may lead to severe irritation. In this case, treatment should be discontinued and appropriate symptomatic therapy should be administered. Preclinical safety data: In animal studies, topical application of benzoyl peroxide to the skin caused minimal to moderate skin irritation, including erythema and edema. Phototoxicity and photoallergic reactions were also observed with the use of benzoyl peroxide.