REFERENCE: FTPR 43 – CE 0477
Medical Device (class IIb) for the treatment of vaginal dryness.
Properties: FTPR 43 is a medical device for the treatment of vaginal dryness. It is a hormone-free lubricating gel thanks to the presence of Polycarbophil and Hyaluronic Acid, it has a protective and emollient action on the vaginal mucosa, improving its turgidity.
It is also useful as an adjuvant in cases of postmenopausal atrophic vaginitis: it forms a protective barrier that reduces symptoms such as burning, itching and pain even during sexual intercourse and promotes the physiologic process of re-epithelialisation in case of microlesions.
Posology and instructions for use:
1 vaginal application for 6 consecutive days, after that 1 application every 3 days or according to medical opinion.
How to apply the cannula:
1. Open the tube using the perforating cap
2. Screw the applicator to the tube
3. Squeeze the tube from bottom until the applicator is completely filled
4. Remove the applicator from the tube, insert it in the vagina and press the plunger until it stops
5. Withdraw the applicator and the plunger, throw the cannula after use.
The applicator (cannula) is disposable.
Throw the cannula after use.
Warnings:
• The applicator (cannula) is disposable.
• Throw the cannula after use.
• There are no known risks associated with the use of the product during pregnancy, however it is recommended to consult a gynecologist before use.
• Do not use in case of allergy to any component.
• Do not use in case of ascertained hypersensitivity to any component of the product.
• Do not exceed the recommended daily dose.
• Do not use after the expiry date.
• The expiry date refers to the product properly stored in intact package.
• Do not swallow.
• Keep out of the reach of children.
• Wash your hands before and after use.
• Compatibility with condoms has not been demonstrated.
• Topical use.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Autorithy. In case of any undesired event always seek for medical advice.
Do not use in case the package is not intact.
Store in its original package at room temperature, in a cool and dry place away from light.
Composition: Purified water, Vegetable Glycerol, Sodium Lactate, Sodium Dehydroacetate, Imidazolidinyl Urea, Sodium Hydroxide, Hydroxyethylcellulose, Asian Centella Phospholipids, Polycarbophil (0,8%), Sodium Hyaluronate (0,5%), Disodium EDTA.
Content total SALE: 30 mL ℮ tube + with 6 disposable cannula for the vaginal application of the device.
Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy.
Revision: February 2024.
