SOFTA-MAN VISCORUB

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ETHANOL; PROPANOL

Available from:

GAMIDA CARE LTD., ISRAEL

ATC code:

D08AX53

Pharmaceutical form:

SOLUTION

Composition:

PROPANOL 18 %W/V; ETHANOL 45 %W/V

Administration route:

CUTANEOUS

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic area:

PROPANOL, COMBINATIONS

Therapeutic indications:

For hygienic and surgical hand disinfection.

Authorization date:

2022-10-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed without a doctor’s prescription
SOFTA-MAN VISCORUB
CUTANEOUS SOLUTION
ACTIVE INGREDIENTS:
Ethanol 45 g/100 ml and propanol 18 g/100 ml
For a list of inactive ingredients and allergens see Section 6.
READ THE ENTIRE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START
USING THIS
MEDICINE. This leaflet contains concise information about this
medicine. If you have
further questions, refer to your doctor or pharmacist.
To use this medicine, follow the instructions in the dosage section of
this leaflet.
Consult the pharmacist if you need more information.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Softa-Man Viscorub is an alcoholic hand disinfectant for hygienic and
surgical hand
disinfection.
THERAPEUTIC GROUP: skin disinfectant.
When used on skin that is not injured, only very small amounts are
absorbed through
the skin and they have no effect on your body.
The active ingredients in Softa-Man Viscorub are ethanol and propanol.
This
medicine is very effective against gram-positive and gram-negative
bacteria,
including antibiotic-resistant strains (such as the
methicillin-resistant Staphylococcus
aureus [MRSA]) and mycobacteria. Softa-Man Viscorub works well killing
fungi and
viruses, and quickly neutralizes rota viruses and viruses that have a
sheath.
2. BEFORE USING THIS MEDICINE
WARNINGS:
• This medicine is for external use only. Avoid all contact with the
eyes and mucous
membranes.
• Do not use on injured skin.
Flammable. The solution’s flash point is 21°C. Keep away from flame
and other
sources of ignition.
Do not smoke, do not swallow.
Do not light a cigarette or expose to fire until the product has dried
completely.
Consult a doctor, pharmacist, or nurse before you start using the
medicine.
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to the active ingredients ethanol and
propanol or
to any of the other ingredients that this medicine contains (see
Section 6 in
this leaflet).
IF

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINE
Softa-Man ViscoRub
Ethanol 45 % w/v ; Propanol 18 % w/v
Cutaneous solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 grams of gel contains 55.70 g of ethanol (96% v/v); 21.00 g of
propanol
For full list of excipients, see
_section 6.1_
.
3.
PHARMACEUTICAL FORM
Viscous non-sterile aqueous solution
4.
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
Softa-Man ViscoRub is indicated for hygienic and surgical hand
disinfection.
4.2
DOSAGE AND ROUTE OF ADMINISTRATION
Topical.
At least 3 ml of undiluted Softa-Man ViscoRub should be applied on the
dry palms of the hands and
rubbed for:
-
at least 30 seconds for hygienic hand disinfection
-
at least 90 seconds for surgical hand disinfection
The skin must remain moist for 30 or 90 seconds, accordingly.
the skin should be left to dry and no rinse is needed.
Softa-Man ViscoRub can be used without prior cleansing of the
handsVisibly dirty hands should be
washed with soap and water first.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients
listed in
_section 6.1_
.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid any contact with eyes and mucous membranes.
Apply only to intact skin.
Flammable (flash point: 21° C). Keep away from any flame or source of
ignition.
No smoking. Do not ingest. For external use only
4.5
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
No interaction study was performed.
4.6
FERTILITY, PREGNANCY AND BREASTFEEDING
Pregnancy
Given that the product is only applied locally to intact skin and that
the absorption of alcohol by the
skin is negligible, Softa-Man ViscoRub can be used in the recommended
manner for hand disinfection
during pregnancy.
Alcohol is a known teratogenic agent in case of systemic absorption
during the use of the product. In
alcohol-dependent mothers, foetal alcohol syndrome was observed in
which babies had specific
characteristics and abnormalities such as microcephaly, low body
weight, and facial abnormalities,
with