Sofargen Spray Medic Powder 10G

Description
CE Class IIA medical device. Non sterile.
Sofargen spray is a powdered spray dressing for topical use containing light kaolin and silver sulfadiazine at a concentration of 1%. 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 contaminated skin lesions of small size such as abrasions, scrapes, cuts, superficial wounds, and dermatitis in general.

Directions for use
Shake the can vigorously for a few seconds before use. After thoroughly cleaning the lesion, ensure that the dispenser nozzle is directed towards the lesion to be treated, holding the can vertically at a distance of about 15 cm from the surface to be treated. Then apply an even layer of Sofargen spray to the lesion, pressing the dispenser button for a few seconds. The application of Sofargen spray should continue uninterrupted once or twice a day until complete healing. After each reapplication, carefully 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 healthy and dry surrounding skin it will tend to remove spontaneously. Where appropriate or necessary, after applying Sofargen spray, cover the lesion with a bandage or dressing 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; anhydrous calcium gluconate 0.1 g; butane as propellant 70.0 g.

Warnings
Patients with confirmed individual hypersensitivity to the components should not use the product.
It is recommended not to use the product for more than 4 weeks. Consult your doctor in case of incomplete healing or if undesirable symptoms appear. Protect your face when spray applying to the upper body. Avoid inhaling the nebulized powder. In case of accidental ingestion or inhalation of the powder, consult a doctor. The powder released exposed to light may tend to turn brown 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 use. For pregnant women and in early childhood, use the product after medical advice. Sofargen spray is intended for the treatment of only small lesions.
Transient sensations of burning or irritation may occur, with no consequences and rare allergic reactions. If side effects occur, consult your doctor or pharmacist.
Pressure container and flammable: do not pierce or tamper with the can in any way, even when empty. The product contains a flammable propellant under pressure: do not use near open flames or heat sources. Exposure to temperatures above 50°C may cause the container to explode. After use, dispose of the can according to current regulations. Contains no ozone-depleting propellants.

Storage
Store at temperatures below 30°C.
Do not use the product beyond the expiration date indicated on the packaging. This date applies to the product in intact, properly stored packaging. Do not store in direct sunlight.
Shelf life when unopened: 36 months.

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

Code 10007056