MATERIAL SAFETY DATA SHEET Product Name CAS # 1 Product and Company Identification CLEARASIL DAILY CLEAR Adult Tinted Acne Treatment Cream Mixture This MSDS is designed for workplace employees, emergency personnel and for other conditions and situations where there is a greater potential for large-scale or prolonged exposure, in accordance with requirements of the US Government's Occupational Safety and Health Administration (OSHA) This MSDS is not applicable for consumer use of our products For consumer use, all precautionary and first aid language is provided on the product label in accordance with the applicable government regulation Product Use Distributed by LEGEND HMIS/NFPA Severe Serious 4 3 Moderate 2 Slight 1 Minimal 0 Emergency overview Topical Skin Preparation Reckitt Benckiser Morris Corporate Center IV 399 Interpace Parkway PO Box 225 Parsippany, NJ 07054-0225 In Case of Emergency: 1-800-338-6167 Transportation Emergencies: 24 Hour Number: North America: CHEMTREC: 1-800-424-9300 Outside North America: 1-703-527-3887 Health / 1 Flammability 0 Physical Hazard 0 Personal Protection 2 Hazards Identification 0 1 0 This product is regulated by the US FDA as an over-the-counter, monograph drug Potential short term health effects Routes of exposure Eyes Skin Inhalation Ingestion Target organs Chronic effects Signs and symptoms OSHA Regulatory Status Warnings: For external use only Do not use on broken skin or large areas of the body When using this product: apply only to areas with acne Rinse eyes right away with water if it gets in eyes Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time If irritation occurs, only use one topical acne medication at a time Stop use and ask a doctor if skin irritation occurs or gets worse If swallowed, get medical help or contact a Poison Control Center right away KEEP OUT OF REACH OF CHILDREN Eye, Skin contact, Inhalation, Ingestion Avoid contact with eyes May cause eye irritation Unlikely to cause skin irritation Not expected to be a skin sensitizer Unlikely to cause irritation due to inhalation Ingestion may cause gastrointestinal irritation Eyes Skin The finished product is not expected to have chronic health effects Symptoms may include redness, edema, drying, defatting and cracking of the skin This acne product is in compliance with Title 21 of the Code of Federal Regulations, Part 207 and meets the regulatory requirements outlined in the OTC Monograph under 21 CFR Part 333 #23223 Page 1 of 9 Issue date 29-Oct-2012
Potential environmental effects Components of this product have been identified as having potential environmental concerns 3 Composition / Information on Ingredients Ingredient(s) CAS # Percent Glyceryl Stearate SE 1302-78-9 11099-07-3 7704-34-9 25-10 25-10 25-10 25-10 1-25 1-25 First aid procedures Eye contact Skin contact Inhalation Ingestion Notes to physician General advice 4 First Aid Measures Avoid contact with eyes Rinse eyes right away with water if it gets in eyes Remove contact lenses If irritation persists, get medical attention Stop use and ask a doctor if skin irritation occurs or gets worse Wash with soap and water Remove to fresh air if inhalation causes eye watering, headaches, dizziness or other discomfort If swallowed, get medical help or contact a poison control center right away DO NOT induce vomiting Rinse mouth out with water Treat patient symptomatically If you feel unwell, seek medical advice (show the label where possible) Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Show this safety data sheet to the doctor in attendance Avoid contact with eyes Keep out of reach of children 5 Fire Fighting Measures Flammable properties Extinguishing media Suitable extinguishing media Unsuitable extinguishing media Protection of firefighters Specific hazards arising from the chemical Protective equipment for firefighters Hazardous combustion products Explosion data Sensitivity to mechanical impact Sensitivity to static discharge Personal precautions Environmental precautions Methods for containment Methods for cleaning up Not flammable by OSHA criteria Water spray Foam Dry chemical Sand Firefighters should wear full protective clothing including self contained breathing apparatus May include and are not limited to: Oxides of carbon 6 Accidental Release Measures Do not touch or walk through spilled material Do not touch damaged containers or spilled material unless wearing appropriate protective clothing Floors may become slippery Keep unnecessary personnel away Do not discharge into lakes, streams, ponds or public waters Advise authorities if product has penetrated drains, sewers or water pipes Stop leak if you can do so without risk Prevent entry into waterways, sewers, basements or confined areas Before attempting clean up, refer to hazard data given above Small spills may be absorbed with non-reactive absorbent and placed in suitable, covered, labelled containers Prevent large spills from entering sewers or waterways Contact emergency services and supplier for advice Never return spills to original containers for re-use #23223 Page 2 of 9 Issue date 29-Oct-2012
Handling Storage Exposure limits Ingredient(s) Glyceryl Stearate SE 7 Handling and Storage For external use only Avoid contact with eyes When using do not eat or drink Ensure adequate ventilation Keep out of reach of children Room temperature - normal conditions Keep from freezing Keep away from heat Keep container tightly closed 8 Exposure Controls / Personal Protection Exposure Limits TWA: 1000 ppm STEL: 1000 ppm TWA: 1000 ppm TWA: 10 ppm STEL: 20 ppm TWA: 10 ppm Engineering controls Personal protective equipment TWA: 10 mg/m3 TWA: 15 mg/m3 Not normally required if good ventilation is maintained Consult the product label for special protection or precautions that have been identified for using this product under directed consumer use conditions The following recommendations are given for workplace employees, emergency personnel and for other conditions and situations where there is a greater potential for large-scale or prolonged exposure Eye / face protection Hand protection Not normally required under normal use conditions When handling in large quantities or responding to emergency situations, the use of appropriate eye protection is recommended Not required When handling in large quantities or responding to emergency situations, the use of appropriate skin protection is recommended #23223 Page 3 of 9 Issue date 29-Oct-2012
Skin and body protection No special requirements under normal use conditions Usual safety precautions while handling the product will provide adequate protection against injury or irritation Respiratory protection Not normally required under normal use conditions General hygiene considerations Avoid contact with eyes Handle in accordance with good industrial hygiene and safety practice When using do not eat or drink Washing with soap and water after use is recommended as good hygienic practice to prevent possible eye irritation from hand contact 9 Physical and Chemical Properties Appearance Glossy cream Color Brown / Orange Form Cream Odor perfumed Odor threshold Physical state Liquid ph 70-85 Freezing point Boiling point Pour point Evaporation rate Flash point Not tested Auto-ignition temperature Flammability limits in air, lower, % by volume Flammability limits in air, upper, % by volume Vapor pressure Vapor density Specific gravity 104-112 Octanol/water coefficient Solubility (H2O) VOC (Weight %) Percent volatile Soluble/Miscible 10 Stability and Reactivity Reactivity This product may react with strong acids Possibility of hazardous reactions Hazardous polymerization does not occur Chemical stability Stable under recommended storage conditions Conditions to avoid Do not mix with other chemicals Incompatible materials Acids Oxidizers Hazardous decomposition products May include and are not limited to: Oxides of carbon Component analysis - LC50 Ingredient(s) 11 Toxicological Information LC50 Glyceryl Stearate SE 31623 ppm rat 5325 mg/l/4h rat 623 mg/l/4h rat #23223 Page 4 of 9 Issue date 29-Oct-2012
Component analysis - Oral LD50 Ingredient(s) LD50 Glyceryl Stearate SE Effects of acute exposure Eye Skin Inhalation Ingestion Sensitization Chronic effects Carcinogenicity 3450 mg/kg mouse; 7060 mg/kg rat 8617 mg/kg rat 301 mg/kg rat > 5000 mg/kg human; 3000 mg/kg rat 24000 mg/kg rat Avoid contact with eyes May cause eye irritation Unlikely to cause skin irritation Not expected to be a skin sensitizer Unlikely to cause irritation due to inhalation Ingestion may cause gastrointestinal irritation The finished product is not expected to have chronic health effects The finished product is not expected to have chronic health effects The finished product is not expected to have chronic health effects Mutagenicity The finished product is not expected to have chronic health effects Reproductive effects The finished product is not expected to have chronic health effects Teratogenicity The finished product is not expected to have chronic health effects Name of Toxicologically Synergistic Products Ecotoxicity 12 Ecological Information Components of this product have been identified as having potential environmental concerns Ecotoxicity - Freshwater Algae - Acute Toxicity Data 72 Hr EC50 Chlorella pyrenoidosa: 11-72 mg/l Ecotoxicity - Freshwater Fish - Acute Toxicity Data 1302-78-9 96 Hr LC50 Oncorhynchus mykiss: 120-160 ml/l [static]; 96 Hr LC50 Pimephales promelas: >100 mg/l [static]; 96 Hr LC50 Pimephales promelas: 13400-15100 mg/l [flow-through] 96 Hr LC50 Salmo gairdneri: 80-190 g/l; 96 Hr LC50 Oncorhynchus mykiss: 19000 mg/l [static] 96 Hr LC50 Pimephales promelas: 534 mg/l; 96 Hr LC50 Oncorhynchus mykiss: 7704-34-9 >100 mg/l [flow-through]; 96 Hr LC50 Pimephales promelas: 36-100 mg/l [static]; 96 Hr LC50 Pimephales promelas: 100 mg/l [flow-through]; 96 Hr LC50 Leuciscus idus: 347 mg/l [static] 96 Hr LC50 Brachydanio rerio: 866 mg/l [static]; 96 Hr LC50 Lepomis macrochirus: <14 mg/l [static]; 96 Hr LC50 Oncorhynchus mykiss: >180 mg/l [static] Ecotoxicity - Water Flea - Acute Toxicity Data 48 Hr LC50 Daphnia magna: 9268-14221 mg/l; 24 Hr EC50 Daphnia magna: 10800 mg/l; 48 Hr EC50 Daphnia magna: 2 mg/l [Static] 48 Hr LC50 Daphnia magna: 78 mg/l Persistence / degradability Bioaccumulation / accumulation #23223 Page 5 of 9 Issue date 29-Oct-2012
Mobility in environmental media Environmental effects Aquatic toxicity Partition coefficient Chemical fate information Disposal instructions Waste from residues / unused products Contaminated packaging 13 Disposal Considerations Review federal, provincial, and local government requirements prior to disposal Do not dispose of large quantities down the drain 14 Transport Information UN/ID No US Department of Transportation (DOT): Classification: Not regulated Proper shipping name US DOT Hazard Class Subsidiary Risk Packing group DOT RQ (lbs) ERG NO Transportation of Dangerous Goods (TDG - Canada): Classification: Not regulated Proper shipping name Status Packing group #23223 Page 6 of 9 Issue date 29-Oct-2012
IMDG (Marine Transport): Classification: Not regulated Proper shipping name Class Subsidiary Risk Packing group IMDG Page Marine pollutant EMS MFAG Maximum Quantity IATA/ICAO (Air): Classification: Not regulated Proper shipping name Class Subsidiary Risk: Packing group Maximum Quantity 15 Regulatory Information Occupational Safety and Health Administration (OSHA) 29 CFR 19101200 hazardous Yes chemical US Federal regulations This product is regulated by the US FDA as an over-the-counter, monograph drug All components of this product are either on the Toxic Substances Control Act list (TSCA) or exempt US - CAA (Clean Air Act) - HON Rule - SOCMI Chemicals Group I US - CAA (Clean Air Act) - Reactivity Factors for VOCs in Aerosol Coatings 169 G Ozone/g VOC Reactivity Factor US - CAA (Clean Air Act) - Volatile Organic Compounds (VOCs) in SOCMI US - CERCLA/SARA - Hazardous Substances and their Reportable Quantities 5000 Lb final RQ; 2270 kg final RQ US - CWA (Clean Water Act) - Hazardous Substances CERCLA (Superfund) reportable quantity : 50000000 #23223 Page 7 of 9 Issue date 29-Oct-2012
Superfund Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Section 302 extremely hazardous substance Immediate Hazard - Yes Delayed Hazard - No Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No No Section 311 hazardous chemical Yes Clean Water Act (CWA) Hazardous substance State regulations This product is not subject to warning labeling under the California Proposition 65 regulation US - California - 8 CCR Section 339 - Director's List of Hazardous Substances 7704-34-9 US - Illinois - Toxic Air Contaminant Carcinogens IARC 2B Carcinogen US - Louisiana - Reportable Quantity List for Pollutants 5000 Lb final RQ; 2270 kg final RQ US - Massachusetts - Right To Know List 7704-34-9 US - Minnesota - Hazardous Substance List Teratogen (dust) US - New Jersey - Right to Know Hazardous Substance List sn 0844 sn 1634 7704-34-9 sn 1757 sn 1861 US - New York - Reporting of Releases Part 597 - List of Hazardous Substances 5000 Lb RQ (air); 1 lb RQ (land/water) US - Pennsylvania - RTK (Right to Know) List 7704-34-9 US - Rhode Island - Hazardous Substance List 7704-34-9 Environmental hazard Toxic; Flammable Toxic Flammable Toxic US - Washington - Dangerous Waste - Dangerous Waste Constituents List US - Washington - Dangerous Waste - Discarded Chemical Products List U201 Inventory status Country(s) or region Inventory name On inventory (yes/no)* United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) #23223 Page 8 of 9 Issue date 29-Oct-2012
16 Other Information Disclaimer This product should only be used as directed on the label and for the purpose intended To the best of our knowledge, the information contained herein is accurate However, neither the above named supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein Final determination of suitability of any material is the sole responsibility of the user All materials may present unknown hazards and should be used with caution Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist Further information CLEARASIL DAILY CLEAR Adult Tinted Acne Treatment Cream, 065 oz - 0279657v20 Issue date 29-Oct-2012 Effective date 15-Oct-2012 Prepared by Reckitt Benckiser Regulatory Department 800-333-3899 Other information For an updated MSDS, please contact the supplier/manufacturer listed on the first page of the document #23223 Page 9 of 9 Issue date 29-Oct-2012