Prontoderm Foam

B. Braun Medical AG

Revision date : 2023-01-19

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Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

27083-27-8

Name of the chemical

Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8

Concentration

0,1-<0

General Information

Version

2.1

Revision date

2023-01-19

Product name

Prontoderm Foam

1.2.1 Relevant identified uses

Cleansing foam for body decolonization including MDRO (MRE, e.g. MRSA, ESBL, VRE) by physical cleansing [MDRO: Multi-Drug-Resistant-Organisms]

supplier name

B. Braun Medical AG

Manufacturer Name

B. Braun Medical AG

Emergency telephone

+49 - (0) 6132 - 84463

Icons in SDS

Company Information

company name

B. Braun Medical AG

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

info.bbmch@bbraun.com, medinfo.bbmuk@bbraun.com, logistics.service@bbraun.com

GHS Information

Signal word

-

Hazard Codes

Hazard statements (CLP)

H412

Hazard statements

Code

Statements

H412

Harmful to aquatic life with long lasting effects

Section 2

SECTION 2: Hazards identification

Classification according to GHS

CLP Regulation Hazardous to the aquatic environment – Chronic Hazard, Category 3 H412 Full text of H- and EUH-statements: see section 16

Adverse physicochemical, human health and environmental effects

Harmful to aquatic life with long lasting effects.

2.2 Label elements

Labelling according to GB CLP Regulation

Hazard statements

H412 - Harmful to aquatic life with long lasting effects. : H412 - Harmful to aquatic life with long lasting effects.

Precautionary statements

P273 - Avoid release to the environment. P501 - Dispose of contents and container to an approved waste disposal plant.

Supplemental label elements

EUH208 - Contains polyhexamethylene biguanide hydrochloride; PHMB. May produce an allergic reaction. : EUH208 - Contains polyhexamethylene biguanide hydrochloride; PHMB. May produce an allergic reaction.

Additional information

This product is not subject to labeling obligation according to art. 1 (5) d) of Regulation (EC) no. : This product is not subject to labeling obligation according to art. 1 (5) d) of Regulation (EC) no.

2.3 Other hazards

This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII Contains no PBT/vPvB substances ≥ 0.1% assessed in accordance with REACH Annex XIII

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