Note: Ingredients listed on restricted chemical lists
EC/CAS
200-661-7/67-63-0
Name of the chemical
Propan-2-ol
Concentration
200- 50-75 661-7
EC/CAS
200-751-6/71-36-3
Name of the chemical
1-butanol
Concentration
0.1-1 200- 751-6
General Information
Revision date
2017-05-08
Product name
Prep Barrier Film
1.2.1 Relevant identified uses
Medical device Telephone: +45 49 11 11 11
Manufacturer Name
Coloplast A/S
Emergency telephone
(DK) +45 82 12 12 12
Icons in SDS
Company Information
company name
Coloplast A/S
e-mail address of the competent person responsible for the Safety Data Sheet
msds@coloplast.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H225, H319, H336
Hazard statements
Code
Statements
H225
Highly Flammable liquid and vapour
Section 2
SECTION 2: Hazards identification
1272/2008 This product is regulated as a medical device in the European Economic Area (EEA). In other regions it may be regulated as a medical device, a cosmetic or not regulated. The product is assessed and supplied with a safety data sheet in accordance with Regulation (EC) no 1272/2008. Labelling of the product is prepared in accordance with Directive 93/42/EEC on medical de- vices and local legislation.
EU Classification
Regulation (EC) No 1272/2008: Flam. Liq. 2;H225 Eye Irrit. 2; H319 STOT SE 3; H336. Wording of H-statements – see section 16. Most serious harmful effects: Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Persons with a known allergy to Terpenes and ter- penoids, sweet orange-oil may exhibit an allergic re- sponse to the product.
2.2 Label elements
The product is a medical device in EAA and therefore the labelling elements from the CLP regulations do not apply, according to Regulation (EC) No 1272/2008, Title I, Article 1, Section 5. The below illustrated hazard statements are therefore only listed in the pre- sent MSDS and not necessarily present on the product labelling.
Hazard statements
Highly flammable liquid and vapour.(H225) Causes serious eye irritation.(H319) May cause drowsiness or dizziness.(H336)
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smok- ing.(P210) Wear protective gloves.(P280) IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre- sent and easy to do. Continue rinsing.(P305/351/338) If eye irritation persists: Get medical advice/attention.(P337/313)
Contains
Terpenes and terpenoids, sweet orange-oil. May produce an allergic reaction (EUH208)
2.3 Other hazards
Assessment to determine PBT and vPvB has not been made.
