Description
CE Class IIA medical device. Non-sterile.
Sofargen spray is a powdered spray dressing for topical use containing light kaolin and 1% silver sulfadiazine. The product remains easily "in situ" and is not affected by the stretching of the wound edges. It can be easily removed by cleaning the lesion with saline solution. It is indicated for the local treatment of small contaminated skin lesions such as abrasions, excoriations, cuts, superficial wounds and dermatological conditions in general.

How to use
Shake the can vigorously for a few seconds before use. After appropriate cleansing of the lesion, ensure that the nozzle of the dispenser is directed towards the lesion to be treated, holding the can vertically at a distance of approximately 15 cm from the surface to be treated. Then apply an even layer of Sofargen spray to the lesion, pressing the dispensing button for a few moments. The application of Sofargen spray should continue without interruption once or twice a day until complete healing. With each new application, thoroughly clean the lesion with water or saline solution. The powder contained in Sofargen spray will tend to adhere to the wound (due to the presence of exudate) or to macerated skin, while on the surrounding healthy and dry skin it will tend to remove itself spontaneously. Where appropriate or necessary, after applying Sofargen spray, cover the lesion with a plaster or bandage depending on its size.
The average duration of the dressing is 12-24 hours.

Components
Light kaolin 9.8 g; micronized silver sulfadiazine 0.1 g; calcium gluconate monohydrate 0.1 g; butane as propellant 70.0 g.

Warnings
Patients with known individual hypersensitivity to the components should not use the product.
It is advisable not to use the product for more than 4 weeks. Consult your doctor if healing is incomplete or if unwanted symptoms occur. Protect your face when spraying on the upper body. Avoid inhaling the nebulized powder. In case of accidental ingestion or inhalation of the powder, consult a doctor. The dispensed powder exposed to light may tend to become brownish, due to the silver ion present in the formulation. However, this phenomenon does not compromise its effectiveness and safety. Do not apply the product together with liquid or solid disinfectants. Replace the cap on the can after each application. In pregnant women and young children, use the product only after consulting a doctor. Sofargen spray should only be used for the treatment of small lesions.
Transient burning or irritation sensations may occur, without consequences, and rare local allergic reactions. If unwanted effects occur, consult your doctor or pharmacist.
Pressurized and flammable container: do not puncture or tamper with the can in any way, even when the product is exhausted. The product contains flammable propellant under pressure: do not use near open flames or heat sources. Exposure to temperatures above 50°C can cause the container to explode. After use, dispose of the can according to current regulations. Does not contain ozone-damaging propellants.

Storage
Store at a temperature below 30°C.
Do not use the product beyond the expiry date indicated on the package. This date refers to the product in intact packaging correctly stored. Do not store in direct sunlight.
Validity of intact packaging: 36 months.

Format
125 ml pressurized can containing 10 g of spray powder.

Code. 10007056