FOILLE SOLE SPRAY CUT 70G

FOILLE THE

active ingredients

100 g cream contain: Active ingredients: Benzocaine alcohol 4 g - Benzocaine 5 g - Cloroxilenol 0.4 g. Excipient(s) with known effects: cetilic alcohol, p-hydroxybenzoate methyl, pidroxybenzoate propile (parabens) and butilidroxyanisol (E320) 100 g of spray contain: Active ingredients: Benzylic alcohol 4 g - Benzocaine 5 g - Cloroxilenol 0.6 g. Excipient(s) with known effects: ethanol and propylene glycol For the full list of excipients, see paragraph 6.1.

Excellent

Cream: stearic acid, cetilic alcohol, glycerin, vaseline oil, isopropylmiristat palmitato and stearate, polysorbate 60, cocoa butter, triethanolamine, carbomer 974P, sorbitan sadarate, p-hydroxybenzoate methyl, eugenol, p-hydroxybenzoate propile, butylhydroxygenate. Spray: ethanol 96%, glucam P 20 (PPG 20 methylglucose ether), spirit of ammonium, glycerol, propylene glycol.

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 cannot be used for ophthalmic use.

Population

Cream: apply the cream, in thin and uniform layer, directly on the lesion. In case of circumscribed lesions it is appropriate - following the application of the cream - then cover with sterile gauze, kept wet with additional applications from the outside and wrap carefully. The dressing should not be removed before 48 hours, in order not to disturb the granulation process. In some cases the initial dressing should not be removed and changed for a longer period of time, however, having to keep it well moistened with FOILLE SOLE. It is recommended not to exceed the maximum limit of 4 applications per day, both in adults and in children. Spray: In case of more extensive injuries, it is preferable to use the spray. When using FOILLE SOLE skin spray, solution, it is necessary to carefully observe the following instructions: 1. shake the tank and then remove the protective capsule; 2. direct the valve hole to the area to be treated keeping it at the distance of about a palm. 3. press the dispenser valve. It is recommended not to exceed the maximum limit of 4 applications per day, both in adult patients and in children.

Conservation

FOILLE SOLE cream: Store at a temperature below 30°C. FOILLE Skin spray, solution: Store at a temperature below 25°C. Keep away from light.

Warnings

FOILLE SOLE is for exclusive external use and should only be used on superficial and non-extended lesions of the skin, and for short periods of time. 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 apply near the eyes. Do not vaporize on flame or on glowing bodies. Do not inhale: the continuous inhalation of FOILLE SOLE spray can induce the appearance of dizziness and feelings of malaise, typical of any aerosol product. The use, especially if prolonged, of the product can give rise to phenomena of sensitization. In this case it is necessary to stop treatment immediately and to establish suitable therapy. The effectiveness and safety of benzocaine depend on a correct dosage. Therefore it is necessary to use the minimum amount 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. 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 SOLE skin spray contains the excipient ethanol (ethyl alcohol). For those who carry out sports activities, the use of drugs containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations. The presence of cetilic alcohol, p-hydroxybenzoate methyl and p-hydroxybenzoate propylene, such as excipients of cream formulation, and propylene glycol, as an excipient of spray formulation, may be responsible for localized skin reactions (also delayed type). The presence of butylhydroxyanionly as excipient of the cream formulation can be responsible for localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

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, stop 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: http://www.agenziafarmaco.gov.it/it/responsabili.

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.

No contraindications are known for the use of FOILLE SOLE during pregnancy or nursing; it is however recommended to consult your physician before taking the medication during pregnancy.

Source: Farmadati