desderman

Leaflet attached to the packaging: information for the user

desderman, 78.2 g/100 g, solution for the skin
Ethanolum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or according to the pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet

• 1. What is desderman and what is it 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 packaging and other information

1. What is desderman and what is it used for

Desderman is an alcoholic medicine for hygienic and surgical hand disinfection.
The antimicrobial spectrum of action includes:
bacteria (including tuberculosis bacilli),
fungi,
viruses: classified as "virucidal" (enveloped and non-enveloped viruses) and "spectrum of virucidal action" (including rotaviruses, adenoviruses, and noroviruses).

2. Important information before using desderman

When not to use desderman:

Warnings and precautions

Desderman is an eye and mucous membrane irritant. It should not be used near the eyes, on damaged skin or mucous membranes. In case of accidental contact with the eyes or mucous membranes, the area should be rinsed immediately with a large amount of water (also under the eyelids). If irritation persists, a doctor should be consulted.
Desderman is intended for external use only. In case of accidental ingestion, medical help should be sought immediately.
In case of mild skin irritation (e.g., dryness) due to frequent use of desderman, skin care should be intensified.
Care should be taken in case of spills of large quantities of desderman, as it is highly flammable (risk of fire and explosion!). In such a case, precautions should be taken immediately: wipe up the spilled liquid, dilute it with a large amount of water, ventilate the room, and remove any ignition sources.
Before using electrical equipment, wait until the medicine has dried. Care should be taken when using the medicine near surfaces sensitive to alcohol.

Pregnancy and breastfeeding

Desderman can 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 the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubt, a doctor or pharmacist should be consulted.
Desderman is intended for use on intact skin. It is applied undiluted without rinsing in the following way:
Adults:

• To perform hygienic hand disinfection, rub the undiluted desderman into dry hands, leaving the skin moist for at least 30 seconds. Virucidal action is achieved within 60 seconds. At least 3 ml of undiluted solution should be used.
• To perform surgical hand disinfection, rub the undiluted desderman into dry hands and forearms, leaving the skin moist for at least 90 seconds. At least 10 ml (2 × 5 ml) of undiluted solution should be used.

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

4. Possible side effects

Like all medicines, desderman can cause side effects, although not everybody gets them.
Rarely(symptoms may occur in up to 1 in 1000 patients)

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

Alcohol-based disinfectants can dry out the skin and cause irritation, especially in low humidity (e.g., in winter).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store desderman

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label after "Expiry date". The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C.
The medicine should be stored in a cool, dry place, away from direct sunlight.
The product is flammable. Flash point: 16°C.
The medicine should be kept away from open flames.
Shelf life after first opening the bottle: 18 months.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. 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 solution for the skin contains 78.2 g of ethanol 96% (v/v), which corresponds to 73.4 g of ethanol 100%.
• The other ingredients are: methyl ethyl ketone, isopropyl myristate, cetyl octanoate, povidone K 30, liquid sorbitol, crystallizing 70%, isopropyl alcohol, purified water.

The active substance "denatured ethanol" contains the denaturant methyl ethyl ketone, which is used to prevent improper use, such as drinking alcohol.

What desderman looks like and what the packaging contains

Desderman is a clear, colorless solution with an alcoholic odor for skin use, which is available in the following packaging sizes and bottles:

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

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Schülke & Mayr GmbH
Robert-Koch-Straße 2
22851 Norderstedt
Germany

Date of last update of the leaflet: 02.09.2021

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Information intended exclusively for healthcare professionals:

Hygienic and surgical hand disinfection — efficacy in in vitroconditions in accordance with test standards