REFERENCE: FTPR 21 – CE 0373
Medical Device (class IIb) for the treatment of microlesions caused by HPV (Human Papilloma Virus) or dryness.
Properties: Protective vaginal cream-gel which, thanks to its properties, carries out a defensive barrier action as an adjuvant in the treatment of intraepitheliomatous lesions caused by HPV (Human Papilloma Virus), improving the process of wound healing.
Medical Device helpful:
• for the control of cervicovaginal transformation zone
• in the treatment of inflammatory and dystrophic diseases and of intraepitheliomatous microlesions (SIL): it helps the re-epithelialization process and the removal of “dead cells”. It favours a better re-epithelialization by keeping the possible micro-wounds clean.
• For the restoration of the normal physiological conditions after diathermocoagulation or colposcopy.
• For the treatment of dry vaginal and vulvar mucosa.
• To restore normal physiological conditions in the post-physical treatment of vulvar condyloma.
In cases of lesions which cause burning and/or itching: it forms a protective film that reduces the pain in a short time, creating the conditions for a faster healing.
Posology and method of administration:
• 1 vaginal application (with cannula) for 6 consecutive days or according to the doctor’s opinion.
• In the post treatment of vulvar condyloma: 2 applications (without cannula) per day for 6 consecutive days or according to the doctor’s opinion.
• In case of intraepithelial lesions (SIL) caused by HPV:
First week: 1 vaginal application (with cannula) for 6 consecutive days
Following weeks: 1 vaginal application (with cannula) twice a week for 3-6 months or according to the doctor’s opinion.
• In case of burning or itching: 1 vaginal application (with cannula) or vulvar (without cannula) per day or according to the doctor’s 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; cannula are disposable (throw the cannula after use).
The applicator (cannula) is disposable.
Throw the cannula after use.
Wash your hands before and after use.
Warnings:
▪ Natural substances that compose the device make it colored therefore, during and after the application, pay particular attention not to stain your clothing;
▪ Do not use it if you are allergic or hypersensitive to any component.
▪ Do not exceed the recommended daily dose.
▪ Do not use after the expiry date printed on the package.
▪ Do not use for purposes other than that for which the product is intended.
▪ Expiry date refers to the product in its intact packaging, and properly stored.
▪ Do not swallow;
▪ Keep out of the reach of children;
▪ In case of burning or persistent itching, consult your doctor;
▪ Compatibility with condoms has not been demonstrated.
▪ 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.
▪ 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.
▪ If you are pregnant or planning a pregnancy you should inform your treating physician that you’re self administering the product.
▪ 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, dry place away from light.
The period of validity after the first opening is 3 months.
Composition: Paraffinum Liquidum (5%), Aloe Barbadensis Leaf Juice (2,5%), Sodium Carboxymethyl Betaglucan 2% solution (2%), Curcuma longa L. (root), Docosanol, Emblica Officinalis Fruit Extract, Polidocanol, Steareth-21, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Potassium cetyl phosphate, Glyceryl Laurate, Sodium Dehydroacetate, Imidazolidinyl Urea, Disodium EDTA, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Sodium Hydroxide, Purified water.
Content total SALE: 30 mL ℮ with 6 disposable cannulae for the vaginal application of the device.
Content total SAMPLE: 10 mL ℮ with 2 disposable cannulae for the vaginal application of the device.
Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy
Revision: September 2025
