ACTION AND MECHANISM

- [ANTI-ACNEIC]. [TOPICAL ANTIBACTERIAL] Active against Propionibacterium acnes, a microorganism implicated in acne vulgaris. It is also [KERATOLYTIC] and [ANTISEBORRHEAIC], counteracting hyperkeratinization and excess sebum secretion associated with acne.

SPECIAL WARNINGS

- If a reaction occurs that suggests sensitivity to any of the components, discontinue application.

SENIORS

No specific geriatric information is available.

PATIENT ADVICE

- Avoid applying to damaged skin, eyes and mouth.- Avoid contact with hair or dyed fabrics, as this may discolor them.- Avoid excessive exposure to the sun or UV radiation.- Notify your doctor and/or pharmacist if you experience any symptoms of an allergic reaction.- Be careful when using flaking, irritating or drying cosmetics as they may increase the irritating effect of benzoyl peroxide.

CONTRAINDICATIONS

- Hypersensitivity to benzoyl peroxide.

PREGNANCY

FDA Category C. It is not known whether it can cause fetal harm when administered to a pregnant woman or if it affects reproductive capacity. However, topical administration is generally considered safe for use during pregnancy. Use in pregnant women only if strictly needed.

PHARMACOKINETICS

Benzoyl peroxide's percutaneous penetration is low; when applied to the skin, it is completely converted to benzoic acid, which is rapidly eliminated in urine.

INDICATIONS

- [ACNE VULGAR] of moderate degree.

INTERACTIONS

No interactions have been reported, and due to its low absorption, they are not expected. However, it is advisable to avoid concomitant administration with azelaic acid and cosmetics that cause peeling, irritating, or drying effects.

LACTATION

It is unknown whether this drug is excreted in breast milk and the possible effects on the nursing infant. Caution is advised.

CHILDREN

The safety and efficacy of this drug in children under 12 years of age have not been established. Not recommended for children under 12 years of age.

RULES FOR CORRECT ADMINISTRATION

Apply a thin film of gel to freshly washed, dry skin with your fingertips, avoiding the eyes, mouth, nostrils, or mucous membranes. If it comes into contact with the eyes, rinse immediately with warm water. Do not apply to damaged or eczematous skin, or to cuts or abrasions. May cause discoloration, so do not allow it to come into contact with any dyed materials (hair, fabrics).

POSOLOGY

Adults, topical: Initial treatment: 1-2 applications daily to the freshly washed and dried affected area. For patients with very sensitive skin, it is advisable to start treatment with one application daily. It is recommended to start with lower concentrations and gradually increase the dose. Improvement may be observed after 4-6 weeks, although longer periods may be necessary.

PRECAUTIONS

- [WOUNDS]. Do not apply to damaged or eczematous skin, cuts, or abrasions due to the possible risk of absorption. Avoid the eyes, mouth, nostrils, or mucous membranes. If product comes into contact with the eyes, rinse immediately with warm water.- [HYPERSENSITIVITY REACTIONS]. If a reaction occurs that suggests sensitivity to any of the components, discontinue use.- Use of cosmetics. Take caution when using cosmetics with flaking, irritating, or drying effects, as these may enhance the irritating effects of benzoyl peroxide.- [PHOTOSENSITIVITY REACTIONS]. Benzoyl peroxide may cause photosensitivity. Avoid excessive exposure to sunlight or UV radiation. It is advisable to use sunscreen or protective clothing.- Avoid contact with the eyes, mucous membranes, inflamed or abraded skin, and hair.- May bleach hair and dyed or colored fabrics.

ADVERSE REACTIONS

The following may appear at the application site:- [WOUNDS]. [DRY SKIN], [SKIN PEELING], [ERYTHEMA] and occasionally [EDEMA].- [HYPERSENSITIVITY REACTIONS]: [CONTACT DERMATITIS] (burning, stinging and redness). In case of excessive [SKIN IRRITATION], remove the product with soap and water and do not reapply until the following day.

COMPOSITION

BENZOYL PEROXIDE: 50 MILLIGRAMS