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Skinman 96 % (V/V) Cutaneous Solution

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ECOLAB

PACKAGE LEAFLET: INFORMATION FOR THE USER Skinman 96 % (v/v) cutaneous solution

Each 100 g Skinman contains 95.7 g denatured Ethanol 96 % (v/v) as its active ingredient.

Read all of this user information carefully because it contains important information for you.

This medicinal product is available without prescription. However, you still need to use Skinman carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve.

-    If you are severely affected by one of the side-effects listed or you notice side-effects that are not mentioned in this user information, please inform your doctor or pharmacist.

This user information contains:

1.    What Skinman is and what it is used for

2.    Before you use Skinman

3.    How to use Skinman

4.    Possible side effects

5.    How to store Skinman

6.    Further information

1.    WHAT SKINMAN IS AND WHAT IS IT USED FOR

Skinman is an alcoholic disinfectant for hygienic and surgical hand disinfection.

2.    BEFORE YOU USE SKINMAN Do not use Skinman

if you are allergic (hypersensitive) to the active substance denatured Ethanol 96 % or to any of the other ingredients..

Take special care with Skinman

-    if large amounts are spilt, as Skinman is highly inflammable (fire and explosion hazard!). If this happens, take precautionary measures immediately: clear up liquid, dilute with lots of water, air the room, and remove any ignition sources.

-    allow the product to dry before using electrical equipment. Take care when using near alcohol-sensitive surfaces.

-    Skinman is an eye and mucosal irritant. Do not use in the eye area, on broken skin or mucous membranes. In case of accidental contact with eyes or mucous membranes, flush immediately with plenty of water (also under the eyelids in the case of the eyes). In case of persistent irritation, consult a doctor.

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- Skinman should only be used externally. In case of accidental swallowing seek medical assistance immediately.

In case of minor skin irritations (e.g. dryness) due to frequent use of Skinman skin care should be intensified.

Using other medicines

There are no known interactions with other medicinal products.

Pregnancy and breast-feeding

Provided that it is used properly, Skinman can be used during pregnancy and breast-feeding.

3.    HOW TO USE SKINMAN Kind of administration:

Cutaneous use

Always use Skinman in accordance with the following instructions: Please ask your doctor or pharmacist for advice if you are not sure or have any concerns.

Hygienic hand disinfection:

Rub undiluted Skinman into dry hands, keeping the skin moist for at least 30 seconds.

Surgical hand disinfection:

Rub undiluted Skinman into dry hands and forearms, keeping the skin moist for at least 90 seconds. Multiple applications of Skinman may be necessary to keep the skin moist for the required time.

Then allow hands to air dry.

For full virucidal efficacy, you must allow an application time of 120 seconds during which time the hands must be kept moist with Skinman. Multiple applications of Skinman may be necessary to keep the skin moist for the required time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicinal products, Skinman can cause side effects, although not everybody gets them.

very common:

affects more than 1 user in 10

common:

affects 1 to 10 users in 100

uncommon:

affects 1 to 10 users in 1,000

rare:

affects 1 to 10 users in 10,000

very rare:

affects less than 1 user in 10,000

In rare cases Skinman may cause skin irritations such as redness and burning. Contact allergies are also possible.

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Disinfecting agents containing alcohol can dry the skin and may cause skin irritations, particularly if air humidity is low (e.g. in winter).

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.

5.    HOW TO STORE SKINMAN

Keep out of the reach and sight of children.

Do not use Skinman after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Shelf life after first opening of the container:

1 year.

Store in a cool dry place, away from direct sunlight. Flammable contents. Product should be kept away from a naked flame.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Skinman contains

Each 100 g of cutaneous solution contains 95.7 g denatured Ethanol 96 % (v/v) (complies to 89.0 g Ethanol).

The other ingredients are:

Denaturing agent: Ethyl Methyl Ketone (1 % v/v)

Macrogol-6-glycerolcaprylo caprate (Ph.Eur.), Lactic acid,

Fragrance (containing orange oil with more than 90 % limonene), Purified water

The active substance “denatured ethanol” contains the denaturing agent ethyl methyl ketone which is used to prevent misuse as drinking alcohol.

What Skinman looks like and contents of the packs

Skinman is a clear, colourless, alcoholic-smelling solution for use on the skin and is available in 100 ml, 500 ml, 1 l and 5 l containers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Ecolab Ltd.

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Lotherton Way, Garforth Leeds, LS25 2JY Tel: +44 (0)113 232 0066 Fax: +44 (0)113 287 1317

This medicinal product is authorised in the Member States under the following names:

DE:    Skinman complete 96 % (v/v) Losung zur Anwendung auf der Haut

UK:    Skinman 96 % (v/v) cutaneous solution

IE:    Skinman 96 % (v/v) cutaneous solution

EL:    Skinman complete 96 % (v/v) AsppaTiKo Siakupa

This leaflet was last approved in 12/2011