BRAUN Softa Man Medical Trade Instructions
- June 13, 2024
- Braun
Table of Contents
BRAUN Softa Man Medical Trade Instructions
Read all of this leaflet carefully because it contains impor-tant information for you.
This medicine is available without prescription. Nevertheless you still need to use Softa-Man carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
In this leaflet:
- What Softa-Man is and what it is used for
- Before you use Softa-Man
- How to use Softa-Man
- Possible side effects
- How to store Softa-Man
- Further information
Softa-Man, cutaneous solution
The active substances are Ethanol (45%) and n-Propanol (18%). The other ingredients are Isopropyl Adipate, PEG-6 Capryl- ic/Capric Glycerides, Dexpanthenol, Bisabolol, Allantoin, Per- fume and Purified Water.
WHAT SOFTA-MAN IS AND WHAT IT IS USED FOR
Softa-Man is an alcoholic hand disinfectant with skin caring agents. It is a clear colourless solution for application on the skin (cutaneous solution).
Softa-Man is intended for hygienic and surgical hand disinfec- tion. The active ingredients, ethanol and n-propanol are effec- tive against bacteria [incl. strains which are resistant against antibiotics, e.g. MRSA (Methicillin Resistant Staphylococcus Aureus)], mycobacteria (incl. mycobacterium tuberculosis), fungi and many viruses (e.g. Hepatitis-B Virus and Hepatitis-C Virus, HI-
Virus, Rota-, Vaccinia-, Herpes-Viruses). Softa-Man is available in bottles of 100 ml, 500 ml, and 1000 ml.
BEFORE YOU USE SOFTA-MAN
Do not use Softa-Man if: you are allergic to ethanol or n-pro- panol or
any of the other ingredients of Softa-Man listed above.
Take special care with Softa-Man if: you develop sensitivity (allergy) to
the product. In this case you should stop using it immediately.
Do not swallow. Do not apply on injured skin, eyes or mucous membranes.
Softa-Man is for external use only. If Softa-Man is accidentally or
deliberately swallowed, seek immediate medical attention.
The solution is flammable (Flash point 21 -22°C). Keep away from sources of
ignition – No smoking.
Pregnancy and breast-feeding: Since Sotfa-Man is applied only locally to
the hands no precautions are necessary.
Driving and using machines: Softa-Man does not affect the ability to
drive or operate machinery.
Using other medicines: Because the product is applied locally on intact
skin, no special restrictions are to be observed.
HOW TO USE SOFTA-MAN
The recommended dosage is
Hygienic hand disinfection:
Rub 3 ml undiluted Sotfa-Man into the hands for 30 seconds until the hands are
dry.
Surgical hand disinfection:
Rub at least 2 x 5 ml undiluted Softa-Man into the hands and forearms. The
skin has to be wetted with Softa-Man over a period of 3 minutes.
Hepatitis-B-prophylaxis:
Rub at least 10 ml undiluted Softa-Man in portions into dry hands. The skin
has to be wetted with Softa-Man over a peri- od of 2 minutes.
POSSIBLE SIDE EFFECTS
Like all medicines, Softa-Man can have side effects. Sensitivi- ty (allergy) to Softa-Man occurs very rarely.
Cases of local alcohol-induced irritation symptoms (e.g. itch- ing, redness, especially atfer frequent application of Softa- Man) are uncommon. Symptoms of dry skin may occur uncommonly in seasons of low air humidity (especially in win- ter). The application of skin caring hand creams after work is recommended in such cases.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORING SOFTA-MAN
- Keep out of the reach and sight of children
- Do not store above 30°C.
- Do not use after the expiry date stated on the label.
- Discard 12 months after first opening of the container.
- This leaflet is revised in Jun 2016
FURTHER INFORMATION
For any information about this medicinal product, please con- tact the local representative of the Marketing Authorisation Holder:
Manufactured by:
B.Braun Medical AG 6204 Sempach Switzerland
Released by:
B.Braun Melungeon AG 34209 Melsungen Germany
Licence Holder in Malaysia:
B.Braun Medical Industries S/B 11900 Bayan Lepas, Penang Malaysia.
