POWDER SPRAY DRESSING WITH KAOLIN AND SILVER SULFADIAZINE 1% SOFARGEN SPRAY 10 G PRESSURIZED CAN 125 ML

Description
CE Class IIA medical device. Non-sterile.
Sofargen spray is a sprayable powder dressing for topical use containing a 1% concentration of light kaolin and silver sulfadiazine. The product easily stays in place and is unaffected by stretching the wound edges. It can be easily removed by cleansing the wound with saline solution. It is indicated for the local treatment of small, contaminated skin lesions such as abrasions, grazes, cuts, superficial wounds, and general dermatological conditions.

How to use
Shake the can vigorously for a few seconds before use. After thoroughly cleansing the wound, be sure to point the nozzle toward the wound to be treated, holding the can upright at a distance of approximately 15 cm from the surface to be treated. Then, apply a uniform layer of Sofargen spray to the wound, pressing the spray button briefly. Continue applying Sofargen spray without interruption once or twice a day until complete healing. After each application, thoroughly cleanse the wound with water or saline solution. The powder contained in Sofargen spray will tend to stick to the wound (due to the presence of exudate) or macerated skin, while on surrounding healthy, dry skin it will tend to remove spontaneously. Where appropriate or necessary, after applying Sofargen spray, cover the wound with a plaster or bandage, depending on its size.
The average length of time the dressing remains on 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 any of the components should not use the product.
It is recommended 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 sprayed powder. If you accidentally swallow or inhale the powder, consult your doctor. The sprayed powder may turn brown when exposed to light, due to the silver ion in the formulation. However, this does not compromise its efficacy and safety. Do not apply the product together with liquid or solid disinfectants. Replace the can cap after each use. For pregnant women and young children, use the product only after consulting your doctor. Sofargen spray should be used for the treatment of small lesions only.
Transient burning or irritation sensations may occur, without any consequences, and rare local allergic reactions may occur. If side effects occur, consult your doctor or pharmacist.
Pressurized and flammable container: do not puncture or tamper with the canister in any way, even after use. 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 burst. After use, dispose of the canister according to applicable regulations. Does not contain ozone-depleting propellants.

Conservation
Store below 30°C.
Do not use the product after the expiration date indicated on the package. This date refers to the product in its intact packaging and stored correctly. Do not store in direct sunlight.
Shelf life in unopened packaging: 36 months.

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

Cod. 10007056