Spirytus hibitanowy 0.5% ats
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE CONDITIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
- 11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
- 12. MARKETING AUTHORISATION NUMBER
- 13. BATCH NUMBER
- 14. AVAILABILITY CATEGORY
- 15. INSTRUCTIONS FOR USE
- 16. INFORMATION PROVIDED IN BRAILLE
INFORMATION ON IMMEDIATE PACKAGING
Plastic bottle
1. NAME OF THE MEDICINAL PRODUCT
SPIRYTUS HIBITANOWY 0,5% ATS, skin solution
2. COMPOSITION OF ACTIVE SUBSTANCE
100 g of skin solution contains 0.5 g of chlorhexidine digluconate.
3. LIST OF EXCIPIENTS
Ethanol 760 g/l, purified water
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
Skin solution
100 ml EAN code: 5909990072958
500 ml EAN code: 5909990072965
600 ml EAN code: 5909990072972
1000 ml EAN code: 5909990072989
5. METHOD AND ROUTE OF ADMINISTRATION
For topical use on the skin.
Indication: an antiseptic solution intended for disinfection of the hands of medical personnel,
patient's skin, and the surgical site prior to procedures.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
The justification for not including an entry in point 6, provided by the responsible party, has been accepted.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Contraindications: do not use in case of diagnosed hypersensitivity to chlorhexidine digluconate,
on burns and open wounds, or for disinfection of mucous membranes.
Do not use in infants and young children.
8. EXPIRY DATE
Expiry date (EXP):
9. STORAGE CONDITIONS
Store below 25°C.
Protect from light. Store in tightly closed containers.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVING FROM IT, IF APPROPRIATE
The justification for not including information in section 10 has been accepted by the responsible entity.
11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
Laboratorium Farmaceutyczne „Labpharm-ATS” Anna Szost, Tadeusz Szost
ul. Mickiewicza 32
05-840 Brwinów
12. MARKETING AUTHORISATION NUMBER
Authorisation No. IL-4289/ZF
13. BATCH NUMBER
Batch number:
14. AVAILABILITY CATEGORY
OTC - Medicinal product available without a doctor's prescription.
15. INSTRUCTIONS FOR USE
Use without dilution.
16. INFORMATION PROVIDED IN BRAILLE
The justification provided by the marketing authorization holder for the absence of Braille labelling has been accepted.