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Panin
Filme
Otolaryngology
Filme Oto

Auricular Spray based on Tocopherol Acetate 

Cleansing and hygiene oil for the external acoustic meatus

Nickel (< 1 ppm) and Gluten (< 10 ppm) tested
Contains no gas
Contains no fragrances, colourants, preservatives and essential oils


20 ml - 0.70 FL. OZ. Bottle
EUROPEAN PATENT


Type of product: CE Class I Medical Device

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FILME OTO promotes delicate and thorough cleansing of the external auditory canal, while respecting its physiological equilibrium.

FILME OTO is an oil based on tocopherol acetate (vitamin E), which promotes delicate and thorough cleansing of the external auditory canal, while respecting its physiological equilibrium. This unique composition is similar to the skin lipids, and helps thin and loosen earwax for easy removal, allowing natural discharge from the ear canal without the use of “cotton swabs”.
FILME OTO is indicated for the prevention and removal of ear wax plugs in children and adults. It is also used in the treatment of chronic eczema of the auditory duct and in subjects wearing hearing aids and head phones for prolonged periods.


MEDICAL DEVICE.
After use, dispose of in accordance with your national legislation. Do not disperse in the environment.
KEEP OUT OF REACH OF CHILDREN


MANUFACTURER:
PANIN S.R.L. a socio unico
Viale della Scienza 24 - 45100 Rovigo (Italy)


EXCLUSIVE SALES LICENCEE FOR ITALY:
HULKA S.R.L. a socio unico
Viale della Scienza, 26 - 45100 Rovigo (Italy)

Tocopherol acetate, Hydrogenated polydecene

Prevention of ear wax build up: 1 squirt in each ear 3 times a week, at least 30 minutes before taking a shower or bath.
To remove ear wax build up: 1 squirt 3 times a day, at least 5 days before removing the wax.
In case of Chronic Eczema of the acoustic meatus apply 1 squirt in each ear once a day for a month.
In subjects wearing external hearing aids apply FILME OTO in the ear canal without prosthesis. The prosthesis can be reinserted 3 hours after using FILME OTO, remove any excess product before reinserting.

Hypersensitive towards the components.
In case of ear infection or perforation of the eardrum consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN.

There are no known interactions with other medicines or products used on ear canal. In the case of application of more than one product leave an interval of at least 5 minutes between each product.
FILME OTO should be applied last.

  1. Position the nozzle perpendicular to the bottle
  2. Before using the first time, pump by depressing 5 times
  3. Tilt your head to one side and introduce the dispenser at the entrance of the ear cavity
  4. Press the dispenser
  5. Wait for a few seconds, lift your head back to position and wipe off any excess
  6. If necessary, repeat the process in the other ear
  7. For prevention leave for at least 30 minutes and then wash normally (bath / shower).
    In case of Cerumen Impaction (Earwax Buildup and Blockage) use before following earwax medical procedure for removal.

For topical ear use.

Although FILME OTO is extremely tolerable, in some rare cases it may cause a stinging effect, irritation, allergic reaction or reddening and swelling at the site of application. If this occurs discontinue use and consult a doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

DO NOT USE AFTER THE INDICATED EXPIRY DATE ON THE INNER AND OUTER PACKAGING.
STORE AT ROOM TEMPERATURE.

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PANIN Srl a socio unico will ensure that the content of the website is accurate, complete and up to date; however, it shall not assume any liability, nor provide or give any express or implied guarantee in respect of possible errors, inaccuracies, omissions, misrepresentations, non-updates, etc. of the site itself and its content, while expressly excluding its liability for any damage, of whatever nature and type, connected with access to this site and the use of its content that takes place at the sole risk and peril of those who access it. Access to and use of this website, as well as any dispute relating to it, are governed exclusively by Italian law, with the exception of the rules of private international law relating to conflicts of law. By visiting its website, PANIN Srl a socio unico does not collect any personal data (e.g. name, address, telephone, e-mail address), unless you agree to provide it voluntarily (e.g. by registering with the website). Any consent may be revoked at any time. You will be able to exercise the rights provided by art. 7 D. Lgs. 30/06/2003, N. 196, in particular, the right to withdraw from the registration at any time and without penalty. The holder of the data processing and in charge of the aforementioned data is PANIN Srl a socio unico, based in Viale della Scienza 24 - 45100 Rovigo Italy.

Panin

Panin S.r.l. a socio unico
Viale della Scienza, 24
45100 Rovigo
Phone number / Fax: (+39) 0425 471323

Register of companies of Rovigo 01178100291
REA n. 133557
VAT number: 01178100291
Cap. Sociale € 50.000,00 i.v.
Società soggetta a direzione e coordinamento di Bio.Lo.Ga. S.r.l.

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