FOILLE BURNS CREAM 29.5G

FOILLE CREMA SCOTTERS

active ingredients

100 g cream contain: Active ingredients: benzyl alcohol 4 g; benzocaine 5 g; chloroxilenol 0.1 g sodium lauril sulphate, eugenolo. For the full list of excipients, see paragraph 6.1.

Excellent

Hydrogenated vegetable oil, ceresine (solid paraffin), yellow beeswax, monodiglycerides (higher fatty acids), corn oil, idrate calcium, sodium borate, PEG 32, sodium lauril sulfate, male dioxide, eugenol, calcium sodium EDTA, 8-hydroxychinoline, purified water.

Therapeutic indications

Minor burns, solar erythys, skin irritations from various chemical-physical agents, insect bites. In the dressing of escoriations, abrasions and superficial wounds of the skin.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. The product is not suitable for ophthalmic use.

Population

Apply the cream, in thin and uniform layer directly on the lesion. In case of circumscribed injuries, it is appropriate - following the application of the cream - to cover with sterile gauze. The dressing should not be removed for at least 48 hours, in order not to disturb the granulation process. In some cases the initial dressing should not be removed and changed even for more time, however, having to keep it well moistened with FOILLE SCOTTATURE. It is recommended not to exceed the maximum limit of 4 applications per day, both in adults and in children.

Conservation

Store at a temperature below 25°C.

Warnings

FOILLE SCOTTATURE is for exclusive external use. The use, especially if prolonged, of the product can give rise to phenomena of sensitization. The effectiveness and safety of benzocaine depend on a correct dosage. Therefore, it is necessary to use the minimum quantity of product sufficient to obtain the desired effect, applying it with caution in subjects with severely damaged mucosa and home of inflammatory processes that could cause excessive absorption of this active ingredient. FOILLE SCOTTATURE should only be used on non-extensive and superficial lesions of the skin and for short periods of time. Do not apply near the eyes. In case of deep wounds, or strewn insect bites, or severe burns, or particularly extensive light burns, always consult your doctor before using the product. If the morbid condition for which this preparation is used persists longer, if irritation arises, whether redness, swelling or pain persist or if you have an infection, suspend use and consult your doctor. Do not use the product in children under 6 months; if recommended administration only after consulting the doctor between 6 months and 2 years of age. FOILLE SCOTTATURE contains sulphate lauril sodium: This medicine contains 60 mg sodium lauril sulphate for 100 g cream equivalent to 0.6 mg/g. Sodium lauril sulphate can cause skin irritation (sting or burning sensation) or intensify reactions on the skin caused by other medicines when applied on the same area. Patients with reduced skin barrier function e.g. as a result of atopic dermatitis are more sensitive to irritant properties of sulphate lauril sodium. FOILLE SCOTTATURE contains eugenol: This medicine contains eugenol allergen that can cause allergic reactions.

Interactions

No notes.

Effects

The use of the products by topical application, especially if prolonged, can give rise to phenomena of sensitization. In this case interrupt treatment and establish suitable therapy. Rarely a high absorption of benzocaine can cause serious reactions (increasing metaemoglobin, with the appearance of cyanosis), especially in children and elderly people, requiring early hospital intervention. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In rare literature there are rare cases of increase in metaemoglobin related to excessive absorption of benzocaine, especially in children and elderly. In case of cyanosis, please contact the nearest hospital for case therapy (support therapy and intravenous administration of methylene blue). In case of accidental ingestion, it is recommended to implement the normal medical measures recommended in case of intoxication.

Contraindications are not known for use in case of pregnancy or breastfeeding. It is however recommended to consult your physician before taking the medication during pregnancy and nursing.

Source: Farmadati