Skinsept Color

Leaflet attached to the packaging: patient information

Skinsept color (45.54 g + 1 g + 27 g) /100 g, solution for the skin

Ethanolum 96 per centum+ Alcohol benzylicus + Alcohol isopropylicus

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. Keep this leaflet, you may need to read it again.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, contact a doctor.

Table of contents of the leaflet:

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

1. What is Skinsept color and what is it used for

This medicine is used for preoperative skin disinfection.
Skinsept color is also intended for skin disinfection before injections,
puncture, vaccinations, and blood sampling.
Skinsept color is a combination medicine containing active substances with known efficacy.
The applied active substances: ethanol, benzyl alcohol, and isopropanol, complement their
ranges of activity, providing broad antiseptic action.
The medicine is effective against bacteria on the skin, including tuberculosis and methicillin-resistant Staphylococcus aureus (MRSA), pathogenic fungi, and viruses such as Hepatitis B, HIV,
Herpes, rotavirus, and adenovirus.
Skinsept color disinfects and degreases the skin, and thanks to the content of dyes, it visualizes the disinfected
area.
The medicine is self-sterilizing. The sterility of the medicine is maintained even in the event of re-contamination (e.g., when opening the packaging) (European Patent No. 0016319).
The medicine does not cause irritation to undamaged skin.

2. Important information before using Skinsept color

When not to use Skinsept color

If the patient is allergic to the active substances or any of the other ingredients of this medicine
(listed in section 6).
The medicine must not be used to disinfect large open wounds. Do not use to disinfect
mucous membranes.
Do not use near the eyes.
Do not use in newborns.

Warnings and precautions

The medicine is flammable. Do not spray near flames. Flash point 21°C (according to DIN standard
51755). Follow the usage times and safety rules for use. Before turning on electrical devices, wait until the medicine has dried. Use with caution on surfaces sensitive to alcohol. Avoid contact with eyes. Protect from high temperatures, sparks, and flames. Open the packaging carefully.

• The medicine is flammable. Do not spray near flames. Flash point 21°C (according to DIN standard 51755). Follow the usage times and safety rules for use. Before turning on electrical devices, wait until the medicine has dried. Use with caution on surfaces sensitive to alcohol. Avoid contact with eyes. Protect from high temperatures, sparks, and flames. Open the packaging carefully.

Skinsept color and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The medicine has not been tested in pregnant women.
No studies have been conducted in animals.
When using the medicine in pregnant women, caution should be exercised.
Breastfeeding
There are no clinical data available.

Driving and using machines

There are no data available on the effect.

3. How to use Skinsept color

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Method of use:
The medicine is for external use only.
Disinfecting the skin before operations and punctures.
Undiluted medicine should be applied with a sterile swab to the skin, spread over the surface, and wait 1 minute until dry. In the event of a risk of HBV, extend the exposure time to 2 minutes, reapplying the medicine to the skin. The procedure should be repeated.
Disinfecting the skin before injections, blood sampling, vaccinations.
The selected skin area should be sprayed before insertion and wait 15 seconds. To broaden the spectrum of action to viruses, extend the exposure time to 1 minute. In the event of a risk of HBV, extend the exposure time to 2 minutes, re-spraying the skin.

Using a larger dose of Skinsept color than recommended

In case of accidental ingestion:
rinse the mouth with water, drink a large amount of water. Medical consultation is necessary.
In case of accidental eye contact:
immediately rinse the eyes with a large amount of running water. Medical consultation is necessary.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Unknown so far.

Reporting suspected side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist, or nurse. Side effects can be reported directly to the Department for the Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301 and fax (22) 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Skinsept color

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label.
Medicines should not be disposed of via wastewater or household waste containers.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the packaging and other information

What Skinsept color contains

100 g of solution contains 45.54 g of ethanol 96% denatured with 1% ethyl methyl ketone (Ethanolum 96 per centum), 1.0 g of benzyl alcohol (Alcohol benzylicus) and 27.0 g of isopropyl alcohol (Alcohol isopropylicus).
Excipients: hydrogen peroxide, orange yellow (E 110), cosmetical red (E 124),
purified water.

What Skinsept color looks like and what the packaging contains

Skinsept color is a red, transparent solution.
It is packaged in 250 ml or 350 ml spray bottles with a pump sprayer.
The elements of the pump sprayer in contact with the medicine are made of the following plastics:
polyoxymethylene (POM)
high-density polyethylene (HDPE)
polypropylene (PP)
polyethylene (PE)
low-density polyethylene (PE-LD)
poly(ethylene-co-vinyl acetate) (EVA)
HDPE bottle with a 1-liter cap
Transparent HDPE canister with a 5-liter cap.

Marketing authorization holder:

Ecolab Sp. z o.o.
ul. Opolska 114
31-323 Kraków
+48 12 2616100

Manufacturer:

Ecolab Deutschland GmbH
Ecolab-Allee 1
D-40789 Monheim am Rhein
Germany
Date of last revision of the leaflet