DESMANOL

DESMANOL care alcohol-based hand disinfection

Important notes (mandatory information)

desmanol care hand disinfectant, solution. Active ingredients: Propan-2-ol, Ethanol 96%.

Areas of application

for hygienic and surgical hand disinfection. Warning: Contains cetyl stearyl alcohol.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Desmanol care hand disinfectant, solution.
Active ingredients: Propan-2-ol, Ethanol 96%.

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, pharmacist, or healthcare professional.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor, pharmacist, or healthcare professional. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet includes

1. WHAT IS DESMANOL CARE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING DESMANOL CARE?
3. HOW TO USE DESMANOL CARE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DESMANOL CARE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS DESMANOL CARE AND WHAT IS IT USED FOR?

Desmanol care is used for hygienic and surgical hand disinfection. The active pharmaceutical ingredients propan-2-ol and ethanol are effective against bacteria (incl. mycobacteria), yeasts * and many viruses. The effectiveness of desmanol care against viruses includes enveloped viruses (classification "limited virucidal")**.
*: according to DGHM/VAH guidelines
**: Tested against test viruses BVDV (surrogate virus for hepatitis C virus) and vaccinia virus.
´
The results, according to current knowledge, allow the conclusion of effectiveness against other enveloped viruses, e.g. hepatitis B virus, HIV.

Areas of application

Hygienic and surgical hand disinfection.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DESMANOL CARE?

Desmanol care must not be used

If you are allergic to propan-2-ol, ethanol or any of the other ingredients of this medicine listed in section 6.
For the disinfection of open wounds, for the antisepsis of mucous membranes and in the immediate vicinity of the eye.

Warning and precautions:

• Please talk to your doctor, pharmacist, or healthcare professional before using desmanol care.
• Do not spray into open flames, keep away from sources of ignition, highly flammable
• Do not ingest!
• In case of eye contact, rinse eyes immediately with plenty of water. Seek medical attention if irritation develops and persists.
• Valid for container sizes from 1000 ml (not relevant for 1000 ml with integrated disposable dosing pump).
• Any decanting may only be carried out under aseptic conditions (sterile bench).

Use of desmanol care with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines. No interactions with other agents are known to date.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Desmanol care contains cetyl stearyl alcohol. Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE DESMANOL CARE?

How much desmanol care and how often should you use desmanol care?
Always use this medicine exactly as described in this package leaflet, or exactly as agreed with your doctor, pharmacist, or healthcare professional. Ask your doctor, pharmacist, or healthcare professional if you are not sure.

Hygienic hand disinfection: Rub original solution for 30 seconds.
Surgical hand disinfection: Rub original solution for 90 seconds.

The hands must be kept moist with the original solution throughout the application time.

If you have used more desmanol care than you should

There is no knowledge of overdosages. However, an overdose is very unlikely with a topical preparation.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, desmanol care can have side effects, although not everybody gets them.

The following frequency information is used to assess side effects:

• Very common: more than 1 in 10 people treated.
• Common: less than 1 in 10 but more than 1 in 100 people treated.
• Uncommon: less than 1 in 100 but more than 1 in 1000 people treated.
• Rare: less than 1 in 1000 but more than 1 in 10,000 people treated.
• Very rare: less than 1 in 10,000 people treated, or unknown.

Possible side effects

Redness and slight burning may occur when rubbing desmanol care into the skin. Allergic reactions (e.g. contact eczema) are also possible.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE DESMANOL CARE?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the label/carton after "Use by".

Storage conditions

Do not refrigerate (at 2-8°C). Do not store above 25ºC.

Note on shelf life after opening or preparation

Desmanol care has a shelf life of 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What desmanol care contains

The active ingredients are: Propan-2-ol 70.0 g, Ethanol, 96% 9.9 g.

The other ingredients are

Purified water, tetradecan-1-ol, cetyl stearyl alcohol (Ph. Eur.), sorbitol solution 70% (crystallizing) (Ph.Eur.), dexpanthenol, ethyl methyl ketone.

What desmanol care looks like and contents of the pack

Desmanol care is a clear, colorless solution and is approved in the following pack sizes:

• 50 ml with hinged lid
• 100 ml with hinged lid
• 500 ml with hinged lid or with integrated disposable dosing pump,
• 1 L with hinged lid or with integrated disposable dosing pump,
• 1 L Euro bottle with screw cap
• 5 L canister with screw cap

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Schülke & Mayr GmbH
D-22840 Norderstedt
info@schuelke.com
Phone +49 40/521 00-0

Source: www.serimed.com and information from the package leaflet
Status: 10/2024
Active ingredients: Propan-2-ol, Ethanol 96%. Areas of application: for hygienic and surgical hand disinfection. Warning: Contains cetyl stearyl alcohol.