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skinsept® color
Medicinal product for skin disinfection
This medical product is used to disinfect the skin before surgery, injections, punctures, blood collection and vaccinations. Skinsept® color is a combination medicine which contains active substances with known efficacy. The active substances used (isopropanol, ethanol and benzyl alcohol) complement one another, ensuring the medicine’s broad-spectrum antiseptic activity. The medicine is effective against the bacteria found on the skin, including mycobacterium tuberculosis and methicillin-resistant Staphylocococcus aureus, pathogenic fungi and viruses: Hepatitis B, HIV, Herpes, rotaviruses and adenoviruses. Skinsept® color disinfects and degreases the skin and, owing to the dyes it contains, makes the disinfected area visible. The preparation is self-sterilising. The preparation remains sterile even in the case of repeated microbiological contamination (e.g. when opening the packaging) (European Patent No 0016319).
Skinsept® color
(45.54 g + 1.0 g + 27 g)/100g solution for cutaneous use
Ethanolum 96 per centum + Alcohol benzylicus + Alcohol isopropylicus
Do not use Skinsept® color:
If the patient is allergic to the active substances or any of the other ingredients of this medicinal product. The medicine should not be used to disinfect large-area open wounds. Do not use to disinfect mucous membranes. Do not apply to the eye area. Do not use in newborns.
Warnings and precautions
The medicine is flammable. Do not spray near flame. Flash point (according to DIN 51755): 21°C. Observe application times and safety rules. Allow wet surfaces to dry before switching on electrical equipment. Use cautiously on alcohol-sensitive surfaces. Avoid contact with eyes. Protect from excessive heat, sparks and flame. Open the packaging carefully.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicinal product.
Pregnancy
The medicine has not been tested in pregnant women. The preparation has also not been tested on animals. Use caution when using the medicine during pregnancy.
Breastfeeding
No clinical data are available.
Driving and operating machinery
No data.
This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
How to use:
For external use only.
Skin disinfection before surgery and punctures.
Apply the undiluted medicine to the skin with a sterile tampon, spread on the surface and wait 1 minute until dry. Where there is a risk of hepatitis virus (HBV) contamination, extend the duration of the procedure to 2 minutes by re-applying the medicine to the skin. Repeat the procedure.
Skin disinfection before injections, blood collection, vaccinations.
Spray the selected area of skin before injection and wait 15 seconds. In order to broaden the spectrum of action to include viruses, extend the duration of the procedure to 1 minute.
Where there is a risk of hepatitis virus (HBV) contamination, extend the duration of the procedure to 2 minutes by spraying the medicine on the skin again.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicinal products, this medicine can cause side effects, although not everybody gets them.
Not known.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse reactions may be reported directly to the
Department for Monitoring Adverse Reactions of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Tel.: +48 22 49 21 301 | Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be obtained.
In the event of adverse reactions, please contact:
Pharmacovigilance contact person: +48 691 190 098
Deputy: +48 508 238 861)
Store below 25°C.
Keep out of sight and out of reach of children.
Do not use after the expiry date.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
What Skinsept® color contains
100 g of the solution contains 45.54 g 96% ethanol contaminated with 1% methyl ethyl ketone, 1.0 g benzyl alcohol and 27.0 g isopropyl alcohol.
Excipients: hydrogen peroxide, sunset yellow (E 110), cochineal red (E 124), purified water.
What Skinsept® color looks like and contents of the package
Skinsept® color is a red, transparent solution.
It is packaged 1 l bottles.
Ministry of Health marketing authorisation No 10729/M/96.
Available packaging
| Unit | Wholesale | Symbol |
|---|---|---|
| 1 l bottle | 12 pcs. | 3005330 |
For more information about the product, please check the label.
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