Foille Sun Skin Cream Benzocaine Burns 30g

NAME
FOILLE SOLE

PHARMACOTHERAPEUTIC CATEGORY
Dermatological; local anesthetics.

ACTIVE PRINCIPLES
Benzyl alcohol; benzocaine; chloroxylenol.

EXCIPIENTS
Cream: stearic acid, cetyl alcohol, glycerin, petroleum jelly oil, isopropyl myristate palmitate and stearate, polysorbate 60, cocoa butter, triethanolamine, carbomer 974P, sorbitan tristearate, methyl p-hydroxybenzoate, eugenol, propyl p-hydroxybenzoate, butylhydroxyanurate . Spray: 96% ethanol, glucam P 20 (PPG 20 methylglucose ether), ammonium spirit, glycerol, propylene glycol.

INDICATIONS
Minor burns, sun rashes, skin irritations from various chemical-physical agents, insect bites; in the dressing of excoriations, abrasions and superficial skin wounds.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the listed excipients; the product cannot be used for ophthalmic use.

DOSAGE
Cream: apply the cream, in a thin and uniform layer, directly on the lesion. In case of limited lesions it is advisable - following the application of the cream - to cover with sterile gauze, kept moist with further applications from the outside and carefully bandage. The dressing should not be removed before 48 hours, in order not to disturb the granulation process. In some cases the initial dressing will not have to be removed and changed even for a longer period of time, but it must be kept well moistened with the drug. It is recommended not to exceed the maximum limit of 4 applications per day, in both adults and children. Spray: in case of more extensive lesions, it is preferable to use the spray. When using the skin spray, solution, it is necessary to carefully observe the following instructions: shake the can and then remove the protective cap; direct the hole of the dispensing valve towards the area to be treated, keeping it at a distance of about a palm; press the dispensing valve. It is recommended not to exceed the maximum limit of 4 applications per day, both in adult patients and in children.

STORAGE
Cream: store below 30 degrees C. Skin spray, solution: store below 25 degrees C; keep away from light.

WARNINGS
The medicine is for external use only and must be used only on superficial and not extensive lesions of the skin, and for short periods of time. In case of deep wounds, or disseminated insect bites, or severe burns or particularly extensive minor burns, always consult your doctor before using the product. If the morbid condition for which this preparation is used persists longer, if irritation occurs, if redness, swelling or pain persists or if you have an infection, discontinue use and consult your doctor. Do not apply near the eyes. Do not vaporize on flames or incandescent bodies. Do not inhale: the continuous inhalation of the spray drug can induce the onset of dizziness and feelings of malaise, typical of any aerosol product. The use, especially if prolonged, of the product can give rise to sensitization phenomena. In this case, treatment must be stopped immediately and appropriate therapy instituted. The efficacy 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 mucous membranes and site of inflammatory processes that could cause excessive absorption of this active ingredient. Do not use the product in children younger 'less than 6 months; administration is recommended only after consulting your doctor between 6 months and 2 years of age. The skin spray drug contains the excipient ethanol (ethyl alcohol). For those who carry out sports activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations. The presence of cetyl alcohol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, as excipients of the cream formulation, and of propylene glycol, as excipient of the spray formulation, can be responsible for localized skin reactions (even delayed type). The presence of butylhydroxyanisole as an excipient of the cream formulation can be responsible for localized skin reactions (eg contact dermatitis) or irritation to the eyes and mucous membranes.

INTERACTIONS
None known.

SIDE EFFECTS
The use of products for topical application, especially if prolonged, can give rise to sensitization phenomena. If so, discontinue treatment and institute appropriate therapy. Rarely, a high absorption of benzocaine can cause serious reactions (increased methemoglobin, with the appearance of cyanosis), particularly in children and the elderly, which require prompt hospital intervention. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
There are no known contraindications for the use of the medicine during pregnancy or breastfeeding; it is however advisable to consult your doctor before taking the drug during pregnancy.