Package leaflet: Information for the patient

Skinsept color (45.54 g + 1 g + 27 g)/100 g, cutaneous solution
Ethanolum 96 per centum + Alcohol benzylicus + Alcohol isopropylicus
Please read this 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, as you may need to read it again.
If you need advice or further information, please consult a pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What Skinsept color is and what it is used for
Important information before using Skinsept color
How to use Skinsept color
Possible side effects
How to store Skinsept color
Contents of the pack and other information

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

This medicine is intended for preoperative skin disinfection.
Skinsept color is also indicated for skin disinfection prior to injections,
punctures, vaccinations, and blood sampling.
Skinsept color is a combined product containing active substances with known efficacy.
The active substances used—ethanol, benzyl alcohol, and isopropyl alcohol—complement each other's activity spectra, providing broad-spectrum antiseptic action.
The product is effective against skin-colonizing bacteria, including Mycobacterium tuberculosis and methicillin-resistant Staphylococcus aureus (MRSA), pathogenic fungi, and viruses such as Hepatitis B, HIV, Herpes, rotaviruses, and adenoviruses.
Skinsept color disinfects and degreases the skin and, due to the presence of dyes, clearly marks the disinfected area.
Skinsept color is self-sterilizing. The sterility of the product is maintained even in the event of microbiological recontamination (e.g., during opening of the container) (European Patent No. 0016319).
The product does not cause irritation of intact skin.

2. Important information before using Skinsept Color

When not to use Skinsept Color
If the patient is allergic to the active substances or to any of the other ingredients of this medicine
(listed in section 6).
Do not use the product for disinfection of large-area open wounds. Do not use for disinfection of
mucous membranes.
Do not use near the eyes.
Do not use in newborns.

Warnings and precautions
The product is flammable. Do not spray near flame. Flash point 21°C (according to DIN
51755 standard). Observe recommended application times and safety instructions. Before switching on
electrical devices, wait until the product has completely dried. Use with caution on surfaces sensitive to
alcohol. Avoid contact with eyes. Protect from high temperatures, sparks, and
flame. Open container carefully.

Skinsept Color and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
The product has not been studied in pregnant women.
Animal studies have not been conducted.
Caution should be exercised when using the product in pregnant women.

Breastfeeding
No clinical data available.

Driving and operating machinery
No data available regarding the effect.

3. How to use Skinsept Color

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Instructions for use:
For external use only.
Skin disinfection prior to surgery and punctures.
Apply the undiluted product with a sterile swab onto the skin, spread it over the surface, and wait 1 minute until dry. In case of risk of hepatitis B virus (HBV), extend the contact time to 2 minutes by reapplying the product to the skin. Repeat the procedure.
Skin disinfection prior to injections, blood collection, and vaccinations.
Spray the selected area of skin before puncture and wait 15 seconds. To broaden the antimicrobial spectrum to include viruses, extend the contact time to 1 minute. In case of risk of hepatitis B virus (HBV), extend the contact time to 2 minutes by respraying the skin.
Use of a larger than recommended dose of Skinsept Color
In case of accidental ingestion:
Rinse mouth with water and drink a large amount of water. Medical advice must be sought.
In case of accidental contact with eyes:
Immediately rinse eyes thoroughly with copious amounts of running water. Medical advice must be sought.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
Currently unknown.
Reporting of suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Skinsept Color

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label.
Medicines must not be disposed of via sewage 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 package and other information

What Skinsept Color contains
100 g of solution contains 45.54 g of 96% ethanol contaminated 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, sunset yellow FCF (E 110), carmine red (E 124), purified water.

What Skinsept Color looks like and contents of the pack
Skinsept Color is a red, transparent solution.
It is packaged in 250 ml or 350 ml spray bottles with a spray pump.
Components of the spray pump that are in contact with the medicinal product 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 cap, 1 l
Canister made of colourless HDPE with cap, 5 l

Marketing Authorisation 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