Bialcol med 0.1% - disinfectant skin solution 300ml

Product Description

Novartis

Skin Solution

Indications

Antisepsis and disinfection of the skin in case of abrasions and wounds.

Contraindications/Side effects

Hypersensitivity to the active ingredient benzoxonium chloride or to any of the excipients listed or to other quaternary ammonium compounds. Do not use in case of penetrating wounds. Do not use in the external auditory canal. Do not use for the disinfection of mucous membranes. Do not use in body cavities or for enemas. Do not use for the disinfection of soft contact lenses.

Dosage

For cutaneous use. Apply a small amount topically, directly or using a sterile gauze/cotton pad, making sure that the liquid does not accumulate in the patient's skin folds, after cleaning the affected area with warm water and drying by tapping lightly with a soft cloth. Repeat the application 4-5 times a day or as needed. Do not exceed the recommended dose and use only for short periods of treatment (3 days).

Warnings

For external use only; do not ingest. Avoid contact with eyes, ears (ear canal), mucous membranes (such as mouth and nose), and deep wounds. In case of accidental contact, rinse thoroughly with plenty of water. Do not use in body cavities or for enemas. If symptoms persist or the condition worsens (the wound is swollen, painful, or accompanied by fever), or if a skin reaction occurs, discontinue use and consult a doctor. Do not use frequently or for a long period of time without consulting your doctor. Do not apply to the breasts during breastfeeding.

Interactions

No interaction studies have been performed. However, the potential for interactions with medicinal products is considered low since benzoxonium chloride is poorly absorbed after topical application. Avoid the simultaneous use of other antiseptics or detergents.

Side effects

In rare cases, skin irritation may occur, which has no consequences and does not require a change in treatment. Prolonged and repeated application of the product to the skin is not recommended as urticaria, angioedema, and anaphylactic reactions may occur. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (>=1/10); common (>=1/100 to <1/10); uncommon (>= 1/1,000 to < 1/100); rare (>= 1/10,000 to < 1/1,000); very rare (< 1/10,000) or not known. Immune system disorders. Very rare: anaphylactic reaction, angioedema, urticaria. Skin and subcutaneous tissue disorders. Rare: skin irritation. Report any suspected adverse reactions via the national reporting system.

Pregnancy and breastfeeding

There are no adequate data from the use of benzoxonium chloride in pregnant women. Foetal toxicity studies in animals suggest no adverse effects. The potential risks for humans are unknown but are likely to be very low as benzoxonium chloride is poorly absorbed after topical application. The medicine can be used during pregnancy in small amounts (on small wounds). It is not known whether benzoxonium chloride is excreted in breast milk. However, it is unlikely that benzoxonium chloride will be present in breast milk in clinically significant amounts, as the product is poorly absorbed after topical application. The medicine can be used during breastfeeding in small amounts (on small wounds) except on the breasts. Newborns should not come into contact with treated skin. No effect of benzoxonium chloride on fertility has been observed in animal studies.