DESDERMAN

Package leaflet: Information for the user

desderman, 78.2 g/100 g, cutaneous solution
Ethanolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by the pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What desderman is and what it is used for
2. Important information before using desderman
3. How to use desderman
4. Possible side effects
5. How to store desderman
6. Contents of the pack and other information

1. What desderman is and what it is used for

desderman is an alcoholic preparation intended for hygienic and surgical hand disinfection.
Microbiological spectrum of activity:
bacteria (including Mycobacterium tuberculosis),
fungi,
viruses: classified as "virucidal" (enveloped and non-enveloped viruses) and classified as "range of virucidal activity" (including rotaviruses, adenoviruses and noroviruses).

2. Important information before using desderman

When not to use desderman:

• if the patient is allergic to ethanol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Desderman is irritating to the eyes and mucous membranes. It must not be used near the eyes, on damaged skin or on mucous membranes. In case of accidental contact with eyes or mucous membranes, immediately rinse the affected area with large amounts of water (including under the eyelids in case of eyes). If irritation persists, consult a doctor.
Desderman is intended for external use only. In case of accidental ingestion, seek immediate medical attention.
In case of mild skin irritation (e.g. dryness) due to frequent use of desderman, intensify skin care measures.
Exercise caution if large quantities of desderman are spilled, as it is highly flammable (risk of fire and explosion!). In such cases, immediately take precautionary measures: wipe up the spilled liquid, dilute it with a large amount of water, ventilate the room, and eliminate all sources of ignition.
Wait until desderman has dried before using electrical equipment. Exercise caution when using the product near surfaces sensitive to alcohol.

Pregnancy and breastfeeding
Desderman may be used during pregnancy and breastfeeding, provided it is used correctly.

3. How to use desderman

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Desderman is intended for application to intact skin. It should be used undiluted and without rinsing, as follows:

Adults:

• For hygienic hand disinfection: Apply undiluted desderman to dry hands and rub thoroughly, keeping the skin wet for at least 30 seconds. Virucidal activity is achieved within 60 seconds. Use at least 3 ml of undiluted solution.
• For surgical hand disinfection: Apply undiluted desderman to dry hands and forearms and rub thoroughly, keeping the skin wet for at least 90 seconds. Use at least 10 ml (2 × 5 ml) of undiluted solution.

Children and adolescents:
The safety and efficacy of desderman in children and adolescents have not been established. Data are not available.
Visible contamination at the pump outlet can be removed by disinfecting through wiping (only for bottles with pump dispenser).

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Rare (symptoms may occur in up to 1 in 1,000 patients)

• Skin irritation, such as redness and burning sensation.
• Contact allergies.

Disinfectants containing alcohol may dry out the skin and cause irritation,
especially under conditions of low air humidity (e.g. during winter).
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al.
Jerozolimskie 181C, PL-02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store the medicine desderman

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: "Expiry date". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in a cool, dry place, away from direct sunlight.
The product is flammable. Flash point: 16°C.
Keep the medicine away from open flames.
Period of use after first opening the bottle: 18 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What desderman contains

• The active substance is ethanol 96% (v/v) ( Ethanolum ). 100 g of the skin solution contains 78.2 g of ethanol 96% (v/v), corresponding to 73.4 g of ethanol 100%.
• Other components are: methyl ethyl ketone, isopropyl myristate, cetyl stearyl octanoate, povidone K 30, sorbitol liquid crystallizing 70%, isopropyl alcohol, purified water.

The active substance "denatured ethanol" contains the denaturing agent methyl ethyl ketone, which
is used to prevent misuse, such as consumption of alcohol.

What desderman looks like and contents of the packaging
Desderman is a clear, colourless alcohol-smelling solution for topical application, available in the following container sizes and types:

• green transparent bottle (HDPE) with a capacity of 100 ml with white "flip-top" cap (PP);
• green transparent bottle (HDPE) with a capacity of 500 ml with white "flip-top" cap (PP);
• green transparent bottle (HDPE) with a capacity of 500 ml with white spray pump (PP);
• green transparent bottle (HDPE) with a capacity of 1000 ml with white "flip-top" cap (PP);
• green transparent bottle (HDPE) with a capacity of 1000 ml with white spray pump (PP);
• green transparent bottle (HDPE) with a capacity of 1000 ml with white screw cap (PP).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Schülke & Mayr GmbH
Robert-Koch-Straße 2
22851 Norderstedt
Germany

Information intended exclusively for healthcare professionals:

Hygienic and surgical hand disinfection — efficacy under in vitro conditions in accordance with test standards