Abrocitinib Oral Suspension

Pfizer Inc

Revision date : 2026-02-16

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

202-318-7/94-26-8

Name of the chemical

Butyl 4-hydroxybenzoate

Concentration

<0.1

EC/CAS

215-185-5/1310-73-2

Name of the chemical

sodium hydroxide

Concentration

0.5%< >=5% <5% 0.5%<

EC/CAS

231-595-7/7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

<25% 017-002- >=25% <25% >=10%

EC/CAS

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

EC/CAS

234-394-2/11138-66-2

Name of the chemical

xanthan gum

Concentration

<1

EC/CAS

231-545-4/7631-86-9

Name of the chemical

Silver adsorbed on silicon dioxide

Concentration

N/A

EC/CAS

259-952-2/99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

0.1-0.5

EC/CAS

202-785-7

Name of the chemical

4-Hydroxybenzoic acid and its Methyl- and Ethyl-esters, and their salts

Concentration

N/A

General Information

Version

5.01

Revision date

2026-02-16

Product name

Abrocitinib Oral Suspension

Product name

Abrocitinib Oral Suspension

Identification on the label/Trade name

Not applicable

Chemical name

Not determined

1.2.1 Relevant identified uses

Pharmaceutical product

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

GHS08 M004 M009 M010 M011 M017

Company Information

company name

Pfizer Inc

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

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H361fd, H412

Hazard statements

Code

Statements

H361fd

Suspected of damaging fertility; Suspected of damaging the unborn child

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Abrocitinib (PF-04965842) Pfizer OEL TWA-8 Hr: Sodium phosphate, dibasic 60 µg/m3 Pfizer Occupational Exposure Band (OEB): PBT & vPvB OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information Chemical name Contains a known or suspected endocrine disruptor.

Signal word

Warning

Hazard statements

H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child H412 - Harmful to aquatic life with long lasting effects

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P273 - Avoid release to the environment P280 - Wear protective gloves and protective clothing P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable

Supplemental label elements

Compound, not fully tested, additional hazards may exist. 1 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 1 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 1 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). 1 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (gas). 1 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (vapor). Unknown aquatic toxicity Contains 0 % of components with unknown hazards to the aquatic environment.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Reproductive toxicity Category 2 - (H361fd) Hazardous to the aquatic environment - chronic Category 3 - (H412) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

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