SECTION 2. - - - - - - - - - COMPOSITION / INFORMATION ON INGREDIENTS - - - - - - - - - - -
This product contains a silver complex, which should be regarded as hazardous to the environment.
However, the concentration of silver is < 1% and according to EC classification criteria the product should
not be classified as dangerous to the environment. Main ingredients and packaging materials are listed
below.
This product consists primarily of polymer materials. Products poses no immediate hazard, but can give
rise to toxic fumes in a fire.
SECTION 4. - - - - - - - - - - FIRST-AID MEASURES - - - - - - - - - -
In Case of Eye Contact : Not relevant
In Case of Skin Contact : This product is intended to be in contact with the skin when used as directed in
the instructions for use
If Inhaled: Not relevant
If Ingested/Swallowed: Not relevant
Other: Show this Safety Data Sheet to a physician or emergency ward.
SECTION 5. - - - - - - - - - - FIRE FIGHTING MEASURES - - - - - - - - - -
Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder or appropriate foam.
Special Firefighting Procedures : Keep personnel removed from and upwind of fire. Wear full fire fighting
turnout gear and respiratory protection.
Exposure Hazard : Smoke, soot, CO/CO2, and other toxic fumes. Avoid contact with heated or molten
product. Do not breathe vapors from heated product.
SECTION 7. - - - - - - - - - - HANDLING AND STORAGE - - - - - - - - - -
Handling: See instructions for use.
Storage: Store until use as supplied and at normal temperatures
SECTION 9. - - - - - - - - - - PHYSICAL AND CHEMICAL PROPERTIES - - - - - - - - - -
Appearance: Wound dressing
Odor: None
Physical State: Solid
pH: Not applicable
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Boiling Point: Not applicable
Melting Point/Freezing Point: Not applicable
Solubility: Not applicable
Density: Not applicable
Flash Point: Unknown
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Form 5.0.0.1CD Corp Rev. 1
SECTION 10. - - - - - - - - - - STABILITY AND REACTIVITY - - - - - - - - - -
Stability: The product is stable under ambient conditions
Conditions to avoid : High temperatures
Materials to avoid: None known
Hazardous Decomposition Products : Heating may produce toxic fumes
Hazardous polymerization : No
SECTION 11. - - - - - - - - - - TOXICOLOGICAL INFORMATION - - - - - - - - - -
This product is a medical device and has been evaluated according to the requirements of medical
devices. According to current knowledge this product is considered non-toxic.
For further information please contact Coloplast A/S at the telephone number found in section 1.
SECTION 12. - - - - - - - - - - ECOLOGICAL INFORMATION - - - - - - - - - -
Ecotoxicological data have not been determined specifically for this product. Based on toxicity data on
the ingredients no ecotoxicological effects are expected. However, the product is not biodegradable and
discharge to the environment should be avoided.
For further information please contact Coloplast A/S at the telephone number found in section 1.
SECTION 13. - - - - - - - - - - DISPOSAL CONSIDERATIONS - - - - - - - - - -
The recommended disposal technology is incineration at any approved facility. The disposal should
always be in compliance with National, Federal, State and local regulations. The product should not be
discharged to the environment.
US: If this product as supplied becomes a waste, is does not meet the criteria of a hazardous waste as
defined under the Ressource Conservation and Recovery Act (RCRA) 40 CFR 261. Under normal private
use the product may be disposed of together with other household waste per RCRA 40 CFR 261.4.B1.
European Union: Per The European Waste Catalogue (EWC), in accordance with EC Directive
75/442/EEC, the following Waste Code can be used: 18 01 04 00 wastes whose collection and disposal is
not subject to special requirements in view of the prevention of infection (e.g. dressings, plaster casts,
linen, disposable clothing, diapers). However, if the waste in view of the prevention of infection needs
special requirements, other Waste Codes should be used. It is the responsibility of the holder of the waste
to determine the actual classification. Waste from private household may be disposed of together with
other household waste.
SECTION 15. - - - - - - - - - - - REGULATORY INFORMATION - - - - - - - - - -
United States: This product is regulated under the Federal Food Drug and Cosmetic Act and do not
require an MSDS for hazard communication as stated in 29 CFR 1910.1200.
This MSDS is supplied as an additional service.
Comment:
European Union: This product is a medical device and is regulated under the Council Directive
93/42/EEC (commonly known as the Medical Device Directive). Medical devices do not require a safety
data sheet for hazard communication.
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Form 5.0.0.1CD Corp Rev. 1
This safety data sheet is supplied as an additional service.
Hazardous chemicals according to Risk Phrase Safety Phrase
Directive 67/548/EEC and later amendments
None None None
THE ABOVE INFORMATION HAS BEEN COMPILED FROM SOURCES BELIEVED TO BE RELIABLE
AND IS ACCURATE TO THE BEST OF OUR KNOWLEDGE. HOWEVER, COLOPLAST CORP.
CANNOT GIVE ANY GUARANTEES REGARDING INFORMATION FROM OTHER SOURCES AND
EXPRESSLY DOES NOT MAKE ANY WARRANTIES, NOR ASSUMES ANY LIABILITY, FOR ITS USE.
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Form 5.0.0.1CD Corp Rev. 1
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