RETIN-A Cream

Janssen Ortho LLC

Revision date : 2014-02-17

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

128-37-0

Name of the chemical

2,6-di-tert-butyl-p-cresol

Concentration

>=0.1-<1%

EC/CAS

302-79-4

Name of the chemical

Tretinoin (INN) (retinoic acid and its salts)

Concentration

>=0.1-<1%

General Information

Version

1.0

Revision date

2014-02-17

Product name

RETIN-A Cream

Product name

RETIN-A Cream

Identification on the label/Trade name

For health and safety information during

Substance name

tretinoin

1.2.1 Relevant identified uses

Finished Pharmaceutical Product, Pharmacotherapeutic group: Anti-acne preparations, This SDS is only intended for occupational use and not for consumer use (see patient packaging insert for consumer use).This SDS is written to provide environmental, health and safety information for personnel that will be handling this finished pharmaceutical

supplier name

Janssen Ortho LLC

Emergency telephone

+18097878541800, +32 14 60 24 44

Icons in SDS

GHS08

Company Information

company name

Janssen Ortho LLC

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

SDSJanssen@its.jnj.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H360

Hazard statements

Code

Statements

H360

May damage fertility or the unborn child

Section 2

SECTION 2: Hazards identification

OSHA Emergency Overview Form cream Colour light yellow Odour no data available Hazard Summary This Finished Pharmaceutical Product is non-hazardous based on chemical classification rules. Refer to the pharmacotherapeutic group (section 1.2) and the patient packaging insert to evaluate the possible workplace hazards when this Finished Pharmaceutical Product is accidently leaking, broken or crushed. GHS Classification Reproductive toxicity Category 1B GHS Label element Hazard pictograms

Signal word

Danger Hazard statements H360 May damage fertility or the unborn child Precautionary statements Prevention P201 Obtain special instructions before use P202 Do not handle until all safety precautions have been read and understood P280 Wear protective gloves/ protective clothing Response P308 + P313 IF exposed or concerned: Get medical advice/ attention Storage P405 Store locked up Disposal P501 Dispose of contents/ container to an approved waste disposal plant Medicinal products in the finished state, intended for the final user, are not subject to GHS labeling. Self-Ignitable no data available

Medical Conditions Generally Aggravated by Exposure

None known. Symptoms of Overexposure Repeated or prolonged skin contact may cause allergic reactions with susceptible persons. Consult the patient packaging insert for more information about this Finished Pharmaceutical Product. Carcinogenicity

2.1 Classification of the substance or mixture

Reproductive toxicity : Category 1B

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