HYDOVAGIN 7 aplikatorów w kartoniku jednostkowym wraz z instrukcją używania. Wersja językowa polska

Organization name

LABORATOIRE L'IDEAL Parisien Sp. z o.o.

SRN

PL-MF-000005402

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Do not use in case of hypersensitivity (allergy) to any of the product ingredients. If burning, itching or redness occur when using the product, stop using it immediately and, if symptoms persist, contact a doctor or pharmacist. Consult a doctor or pharmacist prior to use during pregnancy or breast-feeding. Do not use when attempting to conceive as the gel pH can negatively affect semen. Do not use when menstruating. If vaginal dryness symptoms persist, consult a doctor or pharmacist. If vaginal infection occurs, use the product only after consulting a doctor or pharmacist. Avoid accidental contact of the gel with the mucous membrane of the eye, nose or mouth. Do not use together with local anaesthetics or other vaginal products, including vaginal birth control products, as it may impair their effects. Due to the presence of lactic acid, minor skin reactions may occur (a slight burning or itching sensation), especially in case of excessive vaginal dryness. These symptoms are usually temporary and should disappear naturally. Do not use the product if the applicator is damaged. Do not reuse an open applicator. Do not use after the expiry date. The product is intended for vaginal use only. Do not swallow!

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

05908226260442

Basic UDI-DI

B-05908226260442

Reference / catalog number

HYDOVAGIN 7 aplikatorów w kartoniku jednostkowym wraz z instrukcją używania. Wersja językowa polska

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Gel which creates a protective layer on the mucous membranes that moisturises them and protects them against damage to the epithelial surface resulting from vaginal dryness during sexual intercourse, gynaecological examination or physical activity. Using this medical product improves vaginal elasticity and maintains and restores the vagina’s physiological pH, which helps maintain the correct microbial flora in the vagina and reduces unpleasant smells. Intended for women in their reproductive years and during menopause, in order to alleviate the symptoms of vaginal dryness (discomfort, tension, itching, burning of vaginal mucous membranes) related to: -atrophy of vaginal mucous membranes; -deficiency of oestrogen; -long term stress. In order to help moisturise the vaginal epithelial surface: - after surgical and gynaecological procedures; - after abrasions or other minor mechanical traumas of the vaginal mucous membranes; - after labour; - after chemotherapy, radiotherapy, cryotherapy; - after laser treatments; - at the occurrence of changes resulting from the use of hormonal drugs; - during the perimenopausal period. The gel alleviates abrasions and helps moisturise the vaginal mucous membranes which promotes discomfort reduction during sexual intercourse. The product is also recommended for protection from negative changes in the vagina’s microbial flora and pH (e.g. caused by travelling, swimming-pools, sauna, fitness, antibiotics) through moisturising and maintaining the vagina’s natural pH. The product reduces unpleasant vaginal smell.

Additional information URL

https://www.lideal.pl/

Clinical sizes

• 5 MU03

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS