Dansac Skin Lotion

Dansac A/S

Revision date : 2025-04-16

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GHS02
Health risk rating 1
Safety risk rating 2
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-578-6/64-17-5

Name of the chemical

Ethanol

Concentration

8-10

EC/CAS

231-595-7/7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

<0.1

General Information

Version

1.2

Revision date

2025-04-16

Product name

Dansac Skin Lotion

1.2.1 Relevant identified uses

Ostomy use

supplier name

Dansac A/S

Manufacturer Name

Dansac A/S

Emergency telephone

+45 48465000, +45 82 12 12 12, +353 1 809 2566, +353 1 809 2166, +356 2545 6508

Icons in SDS

GHS02 M004 M009 M017 T013

Company Information

company name

Dansac A/S

e-mail address of the competent person responsible for the Safety Data Sheet

baehsinfo@Hollister.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H226

Hazard statements

Code

Statements

H226

Flammable liquid and vapour

Section 2

SECTION 2: Hazards identification

According to Regulation (EC) No. 1272/2008 (CLP) This product is regulated as a medical device in European Economic Area (EEA) and therefore, is exempt for the requirement to provide a CLP/REACH compliant SDS as it is medical device used in direct physical contact with the human body per Medical Device Regulation (MDR) (2017/745). The information contained within this SDS is provided for the benefit of non-clinical personnel as a guide to handling the product in a non-medical setting. In other regions, it may be regulated as a medical device, a cosmetic or not regulated. Classification of the substance or mixture

Adverse physicochemical, human health and environmental effects

Flammable liquid and vapour

Hazard pictograms

GHS02

Signal word

Warning

Hazard statements

H226 - Flammable liquid and vapour.

Precautionary statements

CLP Label elements are not applicable for medical devices used in direct physical contact with the human body. The product is to be labelled according to the requirements of the medical devices regulations.

Other hazards which do not result in classification

Product contains ethanol. Care should be observed to ensure any potential vapours do not pose a fire hazard. Contains no PBT and/or vPvB substances ≥ 0.1% assessed in accordance with REACH Annex XIII The mixture does not contain substance(s) included in the list established in accordance with Article 59(1) of REACH for having endocrine disrupting properties, or is not identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at a concentration equal to or greater than 0.1 %.

2.1 Classification of the substance or mixture

Classification according to Regulation (EC) No. 1272/2008 [CLP] Flammable liquids, Category 3 H226 Full text of H- and EUH-statements: see section 16 Adverse physicochemical, human health and environmental effects Flammable liquid and vapour.

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