Gentamicin Cream Formulation

Organon & Co

Revision date : 2023-09-30

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GHS08 GHS09
Health risk rating 5
Safety risk rating 1
Environmental risk rating 4

Note: Ingredients listed on restricted chemical lists

EC/CAS

1323-39-3

Name of the chemical

1,2-propyleneglycol monostearate

Concentration

10

EC/CAS

9005-67-8

Name of the chemical

polyethyleneglycol sorbitan monostearate

Concentration

6

EC/CAS

57-11-4

Name of the chemical

stearic acid

Concentration

6

General Information

Version

3.8

Revision date

2023-09-30

Product name

Gentamicin Cream Formulation

1.2.1 Relevant identified uses

Pharmaceutical

Emergency telephone

+55 (19) 3758-2000, +55 (11) 3173-4931

Icons in SDS

GHS08 GHS09 M004 M009 M013 M017 M059

Company Information

company name

Organon & Co

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

EHSSTEWARD@organon.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H360D, H373, H400, H412

Hazard statements

Code

Statements

H360D

May damage the unborn child

Section 2

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Reproductive toxicity : Category 1A Specific target organ toxicity - : Category 2 (Kidney, inner ear) repeated exposure (Oral) Short-term (acute) aquatic : Category 1 hazard Long-term (chronic) aquatic : Category 3 hazard

2.2 Label elements

in accordance with ABNT NBR 14725 Standard

Signal word

Danger

Hazard statements

H360D May damage the unborn child. H373 May cause damage to organs (Kidney, inner ear) through prolonged or repeated exposure if swallowed. H400 Very toxic to aquatic life. H412 Harmful to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention. P391 Collect spillage.

Storage

P405 Store locked up.

Other hazards which do not result in classification

None known.

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