Skinsept Pur

INFORMATION PLACED ON DIRECT PACKAGING

HDPE BOTTLE WITH PUMP

1. NAME OF THE MEDICINAL PRODUCT

Skinsept Pur

(46g + 27g + 1g)/100g, solution
Ethyl alcohol + Isopropyl alcohol + Benzyl alcohol

2. CONTENT OF ACTIVE SUBSTANCES

Composition:
100 g of solution contains as active substances: 46.0 g of ethanol (96% denatured), 27.0 g of isopropyl alcohol, 1.0 g of benzyl alcohol.

3. LIST OF EXCIPIENTS

and excipients: hydrogen peroxide, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Skin solution
350 ml bottle
EAN code: 5909990021505

5. METHOD AND ROUTE OF ADMINISTRATION

Medicine for external use on the skin.
Medicine for skin disinfection before operations, injections, punctures, vaccinations, blood collection, dressing changes.
It is effective against bacteria on the skin (including tuberculosis and MRSA), fungi, and some viruses.
Read the leaflet carefully before using the medicine.

WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT IN

AN INACCESSIBLE PLACE FOR CHILDREN

6.

Store the medicine in a place inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Contraindications:
Skinsept Pur should not be used for umbilical cord disinfection in newborns.
Use cautiously in full-term newborns and only when necessary due to the disinfection procedure.
Use cautiously on surfaces sensitive to alcohol.
The medicine should not be used for disinfection of large open wounds.
The medicine should not be used for disinfection of mucous membranes.
Do not use near the eyes.
Do not use in premature newborns.
The product is flammable; do not spray near an open flame; flash point (according to DIN standard 51755) 21°C; follow application times and safety rules; wait for the medicine to dry before turning on electrical devices; use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

• Use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

Open the packaging carefully.

8. EXPIRY DATE

Expiry date (EXP):
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening – 6 months.

9. STORAGE CONDITIONS

Store at a temperature below 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Ecolab Sp. z o.o.
ul. Opolska 114
31-323 Kraków
Poland

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number: 10728/M/96

13. BATCH NUMBER

Batch number (LOT):

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Instructions for use:
The solution is used undiluted.
Disinfection of the skin before operations and punctures.
The undiluted solution of the medicinal product is applied to the skin using a sterile swab, spread over the skin surface, and left to dry for 1 minute. In the event of a risk of HBV virus, the disinfection procedure should be repeated and the action time extended to 2 minutes.
Disinfection of the skin before injections, blood collection, vaccinations, dressing changes
Spray the skin area before insertion and wait 15 seconds. To extend the spectrum of action to viruses, extend the action time to 1 minute. In the event of a risk of HBV virus, extend the action time to 2 minutes, spraying the skin again.

16. INFORMATION PROVIDED IN BRAILLE

Skinsept Pur

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable

INFORMATION PLACED ON DIRECT PACKAGING

HDPE BOTTLE WITH PP CAP

1. NAME OF THE MEDICINAL PRODUCT

Skinsept Pur

(46g + 27g + 1g)/100g, solution
Ethyl alcohol + Isopropyl alcohol + Benzyl alcohol

2. CONTENT OF ACTIVE SUBSTANCES

Composition:
100 g of solution contains as active substances: 46.0 g of ethanol (96% denatured), 27.0 g of isopropyl alcohol, 1.0 g of benzyl alcohol.

3. LIST OF EXCIPIENTS

and excipients: hydrogen peroxide, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Skin solution
1000 ml bottle
EAN code: 5909990021499

5. METHOD AND ROUTE OF ADMINISTRATION

Medicine for external use on the skin.
Medicine for skin disinfection before operations, injections, punctures, vaccinations, blood collection, dressing changes.
It is effective against bacteria on the skin (including tuberculosis and MRSA), fungi, and some viruses.
Read the leaflet carefully before using the medicine.

WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT IN

AN INACCESSIBLE PLACE FOR CHILDREN

6.

Store the medicine in a place inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Contraindications:
Skinsept Pur should not be used for umbilical cord disinfection in newborns.
Use cautiously in full-term newborns and only when necessary due to the disinfection procedure.
Use cautiously on surfaces sensitive to alcohol.
The medicine should not be used for disinfection of large open wounds.
The medicine should not be used for disinfection of mucous membranes.
Do not use near the eyes.
Do not use in premature newborns.
The product is flammable; do not spray near an open flame; flash point (according to DIN standard 51755) 21°C; follow application times and safety rules; wait for the medicine to dry before turning on electrical devices; use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

• Use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

Open the packaging carefully.

8. EXPIRY DATE

Expiry date (EXP):
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening – 6 months.

9. STORAGE CONDITIONS

Store at a temperature below 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Ecolab Sp. z o.o.
ul. Opolska 114
31-323 Kraków
Poland

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number: 10728/M/96

13. BATCH NUMBER

Batch number (LOT):

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Instructions for use:
The solution is used undiluted.
Disinfection of the skin before operations and punctures.
The undiluted solution of the medicinal product is applied to the skin using a sterile swab, spread over the skin surface, and left to dry for 1 minute. In the event of a risk of HBV virus, the disinfection procedure should be repeated and the action time extended to 2 minutes.
Disinfection of the skin before injections, blood collection, vaccinations, dressing changes
Spray the skin area before insertion and wait 15 seconds. To extend the spectrum of action to viruses, extend the action time to 1 minute. In the event of a risk of HBV virus, extend the action time to 2 minutes, spraying the skin again.

16. INFORMATION PROVIDED IN BRAILLE

Skinsept Pur

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable

INFORMATION PLACED ON DIRECT PACKAGING

HDPE CANISTER WITH HDPE CAP

1. NAME OF THE MEDICINAL PRODUCT

Skinsept Pur

(46g + 27g + 1g)/100g, solution
Ethyl alcohol + Isopropyl alcohol + Benzyl alcohol

2. CONTENT OF ACTIVE SUBSTANCES

Composition:
100 g of solution contains as active substances: 46.0 g of ethanol (96% denatured), 27.0 g of isopropyl alcohol, 1.0 g of benzyl alcohol.

3. LIST OF EXCIPIENTS

and excipients: hydrogen peroxide, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

Skin solution
5000 ml canister
EAN code: 909990021543

5. METHOD AND ROUTE OF ADMINISTRATION

Medicine for external use on the skin.
Medicine for skin disinfection before operations, injections, punctures, vaccinations, blood collection, dressing changes.
It is effective against bacteria on the skin (including tuberculosis and MRSA), fungi, and some viruses.
Read the leaflet carefully before using the medicine.

WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT IN

AN INACCESSIBLE PLACE FOR CHILDREN

6.

Store the medicine in a place inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Contraindications:
Skinsept Pur should not be used for umbilical cord disinfection in newborns.
Use cautiously in full-term newborns and only when necessary due to the disinfection procedure.
Use cautiously on surfaces sensitive to alcohol.
The medicine should not be used for disinfection of large open wounds.
The medicine should not be used for disinfection of mucous membranes.
Do not use near the eyes.
Do not use in premature newborns.
The product is flammable; do not spray near an open flame; flash point (according to DIN standard 51755) 21°C; follow application times and safety rules; wait for the medicine to dry before turning on electrical devices; use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

• Use cautiously on surfaces sensitive to alcohol. Avoid eye contact. Protect from high temperature, sparks, and flames.

Open the packaging carefully.

8. EXPIRY DATE

Expiry date (EXP):
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening – 6 months.

9. STORAGE CONDITIONS

Store at a temperature below 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Ecolab Sp. z o.o.
ul. Opolska 114
31-323 Kraków
Poland

12. MARKETING AUTHORISATION NUMBER

Marketing authorisation number: 10728/M/96

13. BATCH NUMBER

Batch number (LOT):

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

Instructions for use:
The solution is used undiluted.
Disinfection of the skin before operations and punctures.
The undiluted solution of the medicinal product is applied to the skin using a sterile swab, spread over the skin surface, and left to dry for 1 minute. In the event of a risk of HBV virus, the disinfection procedure should be repeated and the action time extended to 2 minutes.
Disinfection of the skin before injections, blood collection, vaccinations, dressing changes
Spray the skin area before insertion and wait 15 seconds. To extend the spectrum of action to viruses, extend the action time to 1 minute. In the event of a risk of HBV virus, extend the action time to 2 minutes, spraying the skin again.

16. INFORMATION PROVIDED IN BRAILLE

Skinsept Pur

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable