SAFETY DATA SHEET - pfizer.com

1 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Silvadene Cream (Silver sulfadiazine)Trade Name:SILVADENEC hemical Family:SulfonamideRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product used as antimicrobialDetails of the Supplier of the SAFETY Data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationNot classified as hazardousLabel ElementsHazard Statements:Not classified in accordance with international standards for workplace HazardsAn Occupational Exposure Value has been established for one or more of the ingredients (seeSection 8).Note:This document has been prepared in accordance with standards for workplace SAFETY , whichrequires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk.

2 The precautionary statements and warning included may not apply in all needs may vary depending upon the potential for exposure in your COMPOSITION / INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Propylene glycol57-55-6200-338-0 Not Listed*_____PZ02568 Version: SAFETY DATA SHEETPage 1 of 9 pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-800-879-3477 pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Revision date: 07-Nov-2017 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 SAFETY DATA SHEET_____3. COMPOSITION / INFORMATION ON INGREDIENTSW hite petrolatum8009-03-8232-373-2 Not Listed*Stearyl Alcohol112-92-5204-017-6 Not Listed*IngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Methylparaben99-76-3202-7 85-7 Not Listed*Silver sulfadiazine22199-08-2244-834-5 Not Listed1 Sorbitan monooleate1338-43-8215-665-4 Not Listed*Isopropyl myristate110-27-0203-751-4 Not Listed*PEG-40 Stearate9004-99-3 Not ListedNot Listed*Water, purified7732-18-5231-791-2 Not Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for accordance with 29 CFR , the exact percentage composition of this mixture hasbeen withheld as a trade FIRST AID MEASURESD escription of First Aid MeasuresEye Contact:Flush with water while holding eyelids open for at least 15 minutes.

3 Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:No data availableMedical ConditionsAggravated by Exposure:None knownIndication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician:None5. FIRE FIGHTING MEASURESE xtinguishing Media:Extinguish fires with CO2, extinguishing powder, foam, or Hazards Arising from the Substance or MixtureHazardous CombustionProducts:Formation of toxic gases is possible during heating or / Explosion Hazards:Fine particles (such as dust and mists) may fuel for Fire-FightersDuring all firefighting activities, wear appropriate protective equipment, including self-contained breathing Name: Silvadene Cream (Silver sulfadiazine)Version: 2 of 9 Revision date: 07-Nov-2017 SAFETY DATA SHEET_____6.

4 ACCIDENTAL RELEASE MEASURESP ersonal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:Contain the source of the spill if it is safe to do so. Absorb spills with non-combustibleabsorbent material and transfer into a labeled container for Consideration forLarge Spills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Cleanup operations should only be undertaken by trained HANDLING AND STORAGEP recautions for Safe HandlingAvoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8).

5 Washthoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical andprocedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potentialpoints of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systemsor other equivalent for Safe Storage, Including any IncompatibilitiesStorage Conditions:Store as directed by product end use(s):Pharmaceutical drug product8. EXPOSURE CONTROLS / PERSONAL PROTECTIONC ontrol ParametersRefer to available public information for specific member state Occupational Exposure ControlsEngineering Controls:Engineering controls should be used as the primary means to control OEL - TWA7 mg/m3 pfizer OEL TWA-8 Hr:White petrolatum2000 g/m3 ACGIH Threshold Limit Value (TWA)5 mg/m3 (oil mist, mineral)Version: Threshold Limit Value (STEL)10 mg/m3 (oil mist, mineral)Propylene glycolStearyl AlcoholPage 3 of 9 Germany - TRGS 900 - TWAs20 ppm224 mg/m3 Australia TWA150 ppm474 mg/m310 mg/m3 Ireland OEL - TWAs150 ppm470 mg/m310 mg/m3 Silver sulfadiazineLatvia OEL - TWA7 mg/m3 Revision date: 07-Nov-2017 Material Name: Silvadene Cream (Silver sulfadiazine) SAFETY DATA SHEET_____8.

6 EXPOSURE CONTROLS / PERSONAL PROTECTIONP ersonal ProtectiveEquipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE). Contact your SAFETY and health professional or SAFETY equipmentsupplier for assistance in selecting the correct protective clothing/equipment based on anassessment of the workplace conditions, other chemicals used or present in the workplace andspecific operational :Impervious gloves ( Nitrile, etc.) are recommended if skin contact with drug product ispossible and for bulk processing operations. (Protective gloves must meet the standards inaccordance with EN374, ASTM F1001 or international equivalent.)Eyes:Wear SAFETY glasses or goggles if eye contact is possible. (Eye protection must meet thestandards in accordance with EN166, ANSI or international equivalent.)Skin:Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing operations.

7 (Protective clothing must meet the standards in accordancewith EN13982, ANSI 103 or international equivalent.)Respiratory protection:Under normal conditions of use, if the applicable Occupational Exposure Limit (OEL) isexceeded, wear an appropriate respirator with a protection factor sufficient to control exposuresto below the OEL ( particulate respirator with a half mask, P3 filter). (Respirators mustmeet the standards in accordance with EN140, EN143, ASTM F2704-10 or internationalequivalent.)9. PHYSICAL AND CHEMICAL PROPERTIESS olvent Solubility:No data availableWater Solubility:No data availablepH:No data Point ( C):No data availableBoiling Point ( C):No data Coefficient: (Method, pH, Endpoint, Value)Decomposition Temperature ( C):No data Rate (Gram/s):No data availableVapor Pressure (kPa):No data available_____PZ02568 Revision date: 07-Nov-2017No data availableOdor:No data monooleateMaterial Name: Silvadene Cream (Silver sulfadiazine)No data availableOdor Threshold:No data StearateNo data availableMolecular Formula:MixturePropylene glycolSilver sulfadiazineNo data availableVersion: petrolatumNo data availableNo data availableMolecular Weight:MixtureStearyl AlcoholWater, purifiedNo data availablePage 4 of 9No data availablePhysical State:CreamMethylparabenNo data availableColor.

8 White to off-whiteIsopropyl myristate SAFETY DATA SHEET_____Vapor Density (g/ml):No data availableRelative Density:No data availableViscosity:No data availableFlammablity:Autoignition Temperature (Solid) ( C):No data availableFlammability (Solids):No data availableFlash Point (Liquid) ( C):No data availableUpper Explosive Limits (Liquid) (% by Vol.):No data availableLower Explosive Limits (Liquid) (% by Vol.):No data available10. STABILITY AND REACTIVITYR eactivity:No data availableChemical Stability:Stable under normal conditions of of Hazardous ReactionsOxidizing Properties:No data availableConditions to Avoid:Fine particles (such as dust and mists) may fuel Materials:As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:No data available11. TOXICOLOGICAL INFORMATIONI nformation on Toxicological EffectsGeneral Information:The information included in this section describes the potential hazards of the Term:Contact with sulfonamides may cause dermatitis.

9 Allergic skin reaction may occur based oneffects of other sulfonamides. Individuals sensitive to this chemical or other materials in itschemical class may develop allergic Clinical Effects:As in all sulfonamide therapy, the following reactions may occur including nausea, vomiting,diarrhea, inflammation of the liver and pancreas, blood disorder, drug fever, skin rash, infectionof the conjunctiva and sclera, blood in the urine and Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the Name: Silvadene Cream (Silver sulfadiazine)Rat Oral LD50 > 20,000 mg/kgRat Oral LD50 > 10 g/kgPropylene glycolVersion: Oral LD 50 22,000 mg/kgIsopropyl myristateMouse Oral LD 50 24,900mg/kgPage 5 of 9 Rabbit Dermal LD 50 20,800mg/kgMouse Oral LD50 49,700 mg/kgRevision date: 07-Nov-2017 Rabbit Dermal LD50 5000 mg/kgSilver sulfadiazinePEG-40 Stearate SAFETY DATA SHEET_____11.

10 TOXICOLOGICAL INFORMATIONI rritation / Sensitization: (Study Type, Species, Severity)Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:Environmental properties have not been :No data availablePersistence and Degradability:No data availableBio-accumulative Potential:No data availableMobility in Soil:No data available_____PZ02568 Stearyl AlcoholSilver sulfadiazineBacterial Mutagenicity (Ames) Salmonella , E. coli NegativeEye Irritation Rabbit MildPropylene glycolSilver sulfadiazineSkin Irritation Rabbit Mild24 Month(s) Rat Dermal NOAEL Not carcinogenicRevision date: 07-Nov-201718 Month(s) Mouse Dermal NOAEL Not carcinogenicSkin Irritation Rabbit MildMaterial Name: Silvadene Cream (Silver sulfadiazine)Silver sulfadiazineEye Irritation Rabbit MildVersion: / Fetal Development Rabbit Oral Dose not specified NOAEL Not teratogenicPage 6 of 9 SAFETY DATA SHEET_____13.