Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
8-15
EC/CAS
232-679-6/9005-25-8
Name of the chemical
Starch
Concentration
N/A
EC/CAS
238-877-9/14807-96-6
Name of the chemical
Talc
Concentration
N/A
EC/CAS
231-545-4/7631-86-9
Name of the chemical
Silver adsorbed on silicon dioxide
Concentration
<0.1
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
9004-65-3
Name of the chemical
methylhydroxypropylcellulose
Concentration
N/A
EC/CAS
77-93-0
Name of the chemical
citric acid, triethyl ester
Concentration
N/A
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
N/A
General Information
Version
4
Revision date
2025-06-16
Product name
Diclofenac and Misoprostol Tablets
Product name
Diclofenac and Misoprostol Tablets
Identification on the label/Trade name
ARTHROTEC; ARTHOTEC; MISOFENAC
Chemical name
Mixture
1.2.1 Relevant identified uses
Pharmaceutical product used as Non-steroidal, anti-inflammatory drug (NSAID)
Icons in SDS
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
Danger
Hazard Codes
Hazard statements (CLP)
H302, H315, H319, H360D
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
OSHA Classification of the substance or mixture Acute toxicity - Oral Skin corrosion/irritation Serious eye damage/eye irritation Reproductive toxicity Category 4 Category 2 Category 1B
2.3 Other hazards
Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).
Signal word
Danger
Hazard statements
H315 - Causes skin irritation H319 - Causes serious eye irritation H302 - Harmful if swallowed H360D - May damage the unborn child
Precautionary statements
P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P280 - Wear protective gloves/protective clothing/eye protection/face protection P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell P330 - Rinse mouth P302 + P352 - IF ON SKIN: Wash with plenty of soap and water P332 + P313 - If skin irritation occurs: Get medical advice/attention P362 + P364 - Take off contaminated clothing and wash it before reuse P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P337 + P313 - If eye irritation persists: Get medical advice/attention P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/ container to an approved waste disposal plant
PBT Substances
& vPvB The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.
2.1 Classification of the substance or mixture
Acute toxicity - Oral Category 4 Skin corrosion/irritation Category 2 Serious eye damage/eye irritation Category 2 Reproductive toxicity Category 1B OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable
