|
|
|
|
|
|
|
|
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Desmila AFI |
Desmila AFI |
Market area: EU |
Market area: EU |
Market area: EU |
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Hygienic I |
Hygienic I |
Market area: EU |
Market area: EU |
Market area: EU |
| Authorisation number |
Authorisation number |
Authorisation number |
|
|
EU-0027707-0030 1-2 |
EU-0027707-0030 1-2 |
EU-0027707-0030 1-2 |
| Common name |
IUPAC name |
Function |
Function |
CAS number |
CAS number |
EC number |
Content (%) |
| Propan-2-ol |
|
Active substance |
Active substance |
67-63-0 |
67-63-0 |
200-661-7 |
64,7 % (w/w) |
|
|
| Identifier |
Meta SPC: Meta SPC 3 |
1.2. Suffix to the authorisation number
1.3. Product type(s)
|
|
| Product type(s) |
PT01: Human hygiene |
| Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
| Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
62,7 - 70 % (w/w) |
|
|
| Formulation type(s) |
Meta SPC 3: CL - Contact gel or Liquid |
|
|
| Hazard statements |
H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4.1. Use description
Table 1
|
|
| Product type |
PT01: Human hygiene |
| Where relevant, an exact description of the authorised use |
Not relevant |
| Target organism(s) (including development stage) |
Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Enveloped viruses Common name: - Development stage: - |
| Field(s) of use |
indoor use For use in private and public areas. |
| Application method(s) |
Method: Direct application to both hands, rubbing Detailed description: - |
| Application rate(s) and frequency |
Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. - Number and timing of application: Up to 5 disinfections per day, 5 day(s) per week |
| Category(ies) of users |
general public (non-professional) |
| Pack sizes and packaging material |
Bottle HD-PE: 0,1L - 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.1. Instructions for use
|
|
|
|
1) |
Comply with the instructions for use. |
|
|
|
| --- |
--- |
--- |
|
2) |
Products must be shaken before use. |
|
|
|
| --- |
--- |
--- |
|
3) |
Only apply on dry and visibly clean hands. |
|
|
|
| --- |
--- |
--- |
|
4) |
For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. |
|
|
|
| --- |
--- |
--- |
|
5) |
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label: — Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap) — Pump spray: Apply 3 pump strokes — Bottle: Visual observation |
5.2. Risk mitigation measures
|
|
|
|
1) |
Avoid contact with eyes. |
|
|
|
| --- |
--- |
--- |
|
2) |
Use by children only under supervision of an adult. |
|
|
|
| --- |
--- |
--- |
|
3) |
Use only in well-ventilated areas. |
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
|
|
|
1) |
If medical advice is needed, have product container or label at hand. |
|
|
|
| --- |
--- |
--- |
|
2) |
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes. |
|
|
|
| --- |
--- |
--- |
|
3) |
Call a POISON CENTER or doctor if you feel unwell. |
|
|
|
| --- |
--- |
--- |
|
4) |
If eye irritation persists: Get medical advice/attention. |
|
|
|
| --- |
--- |
--- |
|
5) |
IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. |
5.4. Instructions for safe disposal of the product and its packaging
|
|
|
|
1) |
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
|
|
|
| --- |
--- |
--- |
|
2) |
Do not let product enter drains. |
|
|
|
| --- |
--- |
--- |
|
3) |
Contact waste disposal services. |
|
|
|
| --- |
--- |
--- |
|
4) |
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
|
|
|
| --- |
--- |
--- |
|
5) |
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
|
|
|
|
1) |
Store in a well-ventilated place. |
|
|
|
| --- |
--- |
--- |
|
2) |
Keep cool. |
|
|
|
| --- |
--- |
--- |
|
3) |
Keep container tightly closed. |
|
|
|
| --- |
--- |
--- |
|
4) |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
|
|
|
| --- |
--- |
--- |
|
5) |
Keep out of reach of children and pets. |
|
|
|
| --- |
--- |
--- |
|
6) |
Shelf-life: 24 months |
-
7.1. Trade name(s), authorisation number and specific composition of each individual product
|
|
|
|
|
|
|
|
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Frend Hand Sanitiser Gel |
Frend Hand Sanitiser Gel |
Market area: EU |
Market area: EU |
Market area: EU |
| Authorisation number |
Authorisation number |
Authorisation number |
|
|
EU-0027707-0031 1-3 |
EU-0027707-0031 1-3 |
EU-0027707-0031 1-3 |
| Common name |
IUPAC name |
Function |
Function |
CAS number |
CAS number |
EC number |
Content (%) |
| Propan-2-ol |
|
Active substance |
Active substance |
67-63-0 |
67-63-0 |
200-661-7 |
65,3 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
|
|
|
|
|
|
|
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Biogat H-Des |
Biogat H-Des |
Market area: EU |
Market area: EU |
Market area: EU |
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Isopropanol 70 biocide C |
Isopropanol 70 biocide C |
Market area: EU |
Market area: EU |
Market area: EU |
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Isopropanol 70 C |
Isopropanol 70 C |
Market area: EU |
Market area: EU |
Market area: EU |
| Trade name(s) |
Trade name(s) |
Trade name(s) |
IsoPure Händedesinfektion |
IsoPure Händedesinfektion |
Market area: EU |
Market area: EU |
Market area: EU |
| Authorisation number |
Authorisation number |
Authorisation number |
|
|
EU-0027707-0032 1-3 |
EU-0027707-0032 1-3 |
EU-0027707-0032 1-3 |
| Common name |
IUPAC name |
Function |
Function |
CAS number |
CAS number |
EC number |
Content (%) |
| Propan-2-ol |
|
Active substance |
Active substance |
67-63-0 |
67-63-0 |
200-661-7 |
70 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
|
|
|
|
|
|
|
|
| Trade name(s) |
Trade name(s) |
Trade name(s) |
Rodalon Hand Sanitizer |
Rodalon Hand Sanitizer |
Market area: EU |
Market area: EU |
Market area: EU |
| Authorisation number |
Authorisation number |
Authorisation number |
|
|
EU-0027707-0033 1-3 |
EU-0027707-0033 1-3 |
EU-0027707-0033 1-3 |
| Common name |
IUPAC name |
Function |
Function |
CAS number |
CAS number |
EC number |
Content (%) |
| Propan-2-ol |
|
Active substance |
Active substance |
67-63-0 |
67-63-0 |
200-661-7 |
63 % (w/w) |
ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj
ISSN 1977-0677 (electronic edition)