======================================================= MSDS Safety Information ======================================================= NAME: ACCUZYME OINTMENT ======================================================= MSDS for ACCUZYME Ointment Page 1 of 4 136095 MATERIAL SAFETY DATA SHEET MSDS No.: U-0134 Prepared: 25 March 2004 Supersedes: HP P-0104.03, dated 5 November 2001 Emergency Number: 1-800-441-8227 SECTION I PRODUCT NAME: ACCUZYME® (Papain-Urea) Debriding Ointment MANUFACTURER: DPT Laboratories, Ltd. 307 East Josephine Street San Antonio, TX 78215-1128 MANUFACTURED FOR: Healthpoint, Ltd. 3909 Hulen Street Fort Worth, TX 76107 PRODUCT TYPE: Topical ointment indicated for the proteolytic debridement of necrotic tissue NFPA HAZARD RATINGS (SCALE 0-4): HEALTH - 1 FIRE - 1 REACTIVITY - 0 SECTION II - Components and Contaminants PRODUCT DESCRIPTION: Formulation is proprietary. This information will be provided, as needed, to medical personnel in the event of an emergency. Hazardous ingredients or ingredients principally responsible for potentially hazardous qualities of this product are listed below. ACTIVE COMPONENTS: Papain 8.3 x 105 units/gram CAS Number: 9001-73-4 Urea 10% w/w 57-13-6 OTHER COMPONENTS: Emulsifying Wax Proprietary Fragrance Proprietary Glycerin 56-81-5 Isopropyl Palmitate 142-91-6 Lactose 63-42-3 Methylparaben 99-76-3 Potassium Phosphate Monobasic 7778-77-0 Propylparaben 94-13-3 Purified Water 7732-18-5 MSDS for ACCUZYME Ointment Page 2 of 4 136095 SECTION III - Physical Data HAZARD DESCRIPTION: A hydrophilic cream-like ointment, which may cause allergic or sensitivity reaction to individuals sensitive to one or more of the components. APPEARANCE: A white to slightly yellow cream pH: 4.3 – 7.0 SOLUBILITY IN WATER: Soluble in water SECTION IV - Fire and Explosion Hazard Data FLASH POINT: Not tested EXTINGUISHER MEDIA: ABC all purpose extinguisher, CO2, foam, dry powder, water (spray) SPECIAL FIRE FIGHTING PROCEDURES: Carbon dioxide and carbon monoxide are possible pyrolysis products from this material. SCBA. OBA or other similar equipment may be required for fires involving large inventories of this material stored in enclosed spaces. UNUSUAL FIRE AND EXPLOSION HAZARD: This product is an aqueous cream and should not present a fire or explosion hazard. SECTION V - Reactivity Data REACTIVITY: N/A CONDITION(S) TO AVOID: Excessive heat above 86°F for prolonged periods. INCOMPATIBILITIES: Strong oxidizers. HAZARDOUS DECOMPOSITION: Acrolein, Carbon dioxide and carbon monoxide and oxides of phsophorousmay be produced during pyrolysis. HAZARDOUS POLYMERIZATION: None known SECTION VI - Health Effects and First Aid Papain is a sensitizer. This product is considered safe for its intended use, however, as is the case with all topical products, a small number of individuals may experience reactions such as redness, rash and/or swelling. Use of this product should be discontinued any time a reaction occurs. A physician, emergency room or Poison Control Center should be called any time the product is ingested orally. ROUTES OF ENTRY: Dermal, ocular, oral SYMPTOMS OF EXPOSURE: Minimal, irritation in sensitive individuals FIRST AID EYE AND MUCOUS MEMBRANE CONTACT: Remove contact lens if worn. Flush with water for 15 minutes. Hold eyelids open to assure complete contact with water. Protect unaffected eye. If irritation persists, seek medical attention. MSDS for ACCUZYME Ointment Page 3 of 4 136095 SECTION VI - Health Effects and First Aid (continued) SKIN CONTACT: Should skin irritation, allergic reaction, or rash occur, remove contaminated clothing if required, then physically remove as much of the product as possible. Wash affected area with soap and water, then thoroughly flush the area with water. If irritation persists, seek medical attention. INGESTION: Product is water soluble with low toxicity. Do not induce vomiting as aspiration of the product might occur. Drink large amounts of water slowly. In cases where the ingestion of a large amount is suspected, experienced medical personnel may perform gastric lavage. INHALATION: N/A CARCINOGENICITY: Not tested. Product does not contain any chemical included in the State of California Environmental Protection Agency listing of chemicals known to the state to cause cancer or reproductive toxicity (Proposition 65 List). None of the ingredients in this product are listed by International Agency for Research on Cancer (IARC), National Toxicology Program (NTP), or Occupational Safety and Health Administration (OSHA) as carcinogens. MEDICAL CONDITIONS USUALLY AGGRAVATED BY EXPOSURE: None known. SECTION VII - Storage and Handling Precautions STORAGE: • Protect from freezing • Store in a cool place, 8ºC – 15ºC (46ºF – 59ºF). Alternatively may be stored in a refrigerator. PROTECTIVE EQUIPMENT: Wear safety glasses with side shields if eye contact is likely, e.g., during clean up of large spill. Wear gloves, lab coat, or other protective over-garment if skin contact is likely, e.g., during clean up of large spill. SPILL: • Small Spills – Scoop material and place in a suitable container. Use soap and water to clean the area, absorb with paper towel or other appropriate media. • Keep product out of drains; prevent entry to surface water, groundwater and soil. • Large spills can be vacuumed or scooped and placed in a suitable container. All ignition sources should be removed. Use soap and water to clean the area, absorb with paper towel or other appropriate media. DISPOSAL: Material should be disposed of by placing in a landfill or by incineration in accordance with relevant Federal, State, and Local regulations. This product does not meet the definition of hazardous waste as defined in 40 CFR 261.11. SECTION VIII – Special Protection Information The following information assumes large quantities of the product such as might be encountered in warehouse storage or an industrial accident. VENTILATION: No special requirements. FIRE FIGHTING: Use ABC all purpose extinguisher media or CO2, foam, dry powder, water (spray) SPECIAL PRECAUTIONS: None. RESPIRATORY PROTECTION: SCBA, OBA or other similar equipment may be required for fires involving large inventories of this material stored in enclosed spaces. MSDS for ACCUZYME Ointment Page 4 of 4 136095 SECTION IX – Toxicological Information SKIN: Accuzyme ointment – Repeat Insult Patch Test – Human, no indication of a potential for dermal irritation or sensitization SECTION IX - Transportation and Shipping Information DOT Class Consumer Commodity ORM-D. ***************************************************************************************************** The information contained herein is furnished without warranty of any kind. The above information is believed to be correct but does not purport to be all-inclusive and should be used only as a guide. Users should make independent determinations of the suitability and completeness of information from all sources to assure proper use and disposal of these materials and the safety and health of employees and customers. *****************************************************************************************************