REFERENCE: FTPR 09 – CE 0373
Medical Device (class IIb) for the treatment of vaginal dryness.
Properties: Medical Device is suitable for postmenopausal women suffering from symptoms of atrophic vaginitis carrying out an adjuvant re-epithelization processes in case of micro-lesions that can cause burning, itching or pain during sexual intercourses. Its specific formula creates a mucoadhesive protective film with a barrier effect in the vaginal mucosa.
Posology and method of administration:
1 vaginal application for 6 consecutive days or according to medical opinion.
In complementary use to estrogenic or estro-progestinic therapy: apply the product locally every day for 6 days, then 1 application every 2 days for a week, proceed with single or bi-weekly applications depending on the need, 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; cannulae are disposable (throw the cannula after use).
The applicator (cannula) is disposable. (only for configuration with 6 cannulae)
The applicator (cannula) is multiuse. (only for configuration with 1 cannula)
Carefully wash the cannula after use with water and soap. (only for configuration with 1 cannula)
Once the product is finished, throw also the cannula. (only for configuration with 1 cannula)
Throw the cannula after use. (only for configuration with 6 cannulae)
Wash your hands before and after use.
Warnings:
▪ Do not use the product after the expiry date printed on the package.
▪ In case of burning or persistent itching, consult your doctor
▪ Expiry date refers to the product in its intact packaging, and properly stored.
▪ Do not swallow;
▪ Keep out of the reach of children;
▪ Compatibility with condoms has not been demonstrated.
▪ Use reserved for post-menopausal women.
▪ The use of cannula is for strictly personal individual use.
▪ Once the product is finished, throw also the cannula. (only for configuration with 6 cannulae)
▪ Do not exceed the recommended daily dose.
▪ Do not use it if you are allergic or hypersensitive to any component.
▪ In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use.
▪ No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor.
▪ Do not use for purposes other than that for which the product is intended.
▪ If after a short period of treatment (6 days) you do not notice appreciable results or an improvement in symptoms, contact your doctor; in any case, do not use continuously for more than 30 days.
▪ Any serious incident related or concomitant to the use of the device must be immediately reported to Manufacturer and to 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.
The period of validity after the first opening is 3 months.
Composition: Centella Asiatica extract (1%), Xyloglucan from Tamarindus (1%), Sodium hyaluronate powder (0,5%), Glycerin E422, Sodium lactate, Sodium dehydroacetate, Sodium hydroxide, Imidazolidinyl urea, Hydroxyethylcellulose, Polycarbophil, Zanthoxylum bungeanum extract, Disodium EDTA, Purified Water.
Content total SALE: 30 mL ℮ with 6 disposable cannulae for the vaginal application of the device.
Content total SAMPLE: 10 mL ℮ with 1 disposable cannula for the vaginal application of the device.
Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy.
Revision: September 2025
