Material Safety Data Sheet

Transcription

1 Page 1 of 6 Material Safety Data Sheet Printing date 10/09/2000 Revised On 10/09/ Identification of substance Product details Name: Afrin No-Drip Nasal Sprays MSDS Number: SP TRADENAMES/SYNONYM(s): Afrin No-Drip Nasal Spray Afrin No-Drip Extra Moisturizing Nasal Spray Afrin No-Drip Sinus Nasal Spray Afrin Severe Congestion No-Drip Nasal Spray Manufacturer/Supplier: Schering-Plough HealthCare Products, Inc Jackson Avenue Memphis, TN Information department: Schering-Plough MSDS HelpLine: (800) (US & Canada) (908) (Worldwide) Emergency information: CHEMTREC (800) Composition/Data on components Chemical formula: Proprietary information. Chemical characterization Description: The formulations for these products are proprietary information and are mixtures of hazardous and/or non-hazardous materials. These mixtures contain the listed hazardous components in concentrations >1%; other hazardous components may be present in concentrations <1%. No carcinogens or potential carcinogens listed by NTP, IARC, or OSHA are present in concentrations >0.1% in these mixtures. Hazardous components: Oxymetazoline hydrochloride 0.05% 3 Hazards identification EMERGENCY OVERVIEW:

2 Page 2 of 6 Slightly opaque liquid with characteristic odor. May cause intranasal stinging. May cause cumulative effects. Potential Health Effects: Although some components that are used in the manufacture of this product are considered hazardous on an individual basis, the final formulation of this product is considered non-hazardous when used according to manufacturer's directions. The active ingredient in these products, oxymetazoline hydrochloride, is an andrenergic (vasoconstrictor) drug which can be toxic if ingested in larger than therapeutic quantities. Oxymetazoline hydrochloride can cause stinging, burning, and dryness of the nasal mucosa, sneezing, headache, lightheadedness, insomnia, elevated blood pressure, nausea, dizziness, nervousness, and changes in heart rate. Use of these products can cause intranasal stinging. Frequent or prolonged use may cause nasal congestion symptoms to recur or worsen. Use only as directed. These products should not be used by persons with heart disease, high blood pressure, thyroid disease, diabetes, or prostate gland enlargement. Additional information: This MSDS is written to provide health and safety information for individuals who will be handling the final product. For health and safety information for individual components during manufacturing, refer to the appropriate MSDS of each component. No carcinogens or potential carcinogens listed by NTP, IARC, or OSHA are present in concentrations >0.1% in this mixture. 4 First aid measures Respiratory: Remove from exposure. If breathing ceases, give artificial respiration. Get medical attention immediately. Dermal: Remove contaminated clothing. Wash exposed area with soap and water. Get medical attention immediately. Eye: Rinse opened eye for 15 minutes under running water or with normal saline solution. Get medical attention immediately. Ingestion: In case of accidental swallowing, give large amounts of water and induce vomiting, if conscious. Get medical attention immediately. Information for physician:

3 Page 3 of 6 Oxymetazoline hydrochloride is an alpha-2a agonist with sympathomimetic activity. Treat symptomatically. 5 Fire fighting measures Suitable extinguishing agents: Water, dry chemical, or CO2. Special hazards caused by the material, its products of combustion or resulting gases: Under normal conditions of use, this material does not present a significant fire or explosion hazard. Protective equipment: Wear full protective clothing and self-contained breathing apparatus (SCBA). 6 Accidental release measures Measures for environmental protection: Spills should be handled in accordance with standard operating procedures. Chemical decontamination is recommended. Measures for cleaning/collecting: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). 7 Handling and storage Handling: Ensure adequate ventilation. Keep containers tightly closed when not in use. Storage: Store between 2 and 30 degrees C (36 and 89 degrees F). 8 Exposure controls and personal protection Engineering Controls: Provide adequate ventilation. Occupational Exposure Guidelines and Standards Not Available. Breathing equipment: Use suitable respiratory protective device in case of insufficient ventilation. Skin protection:

4 Page 4 of 6 Gloves appropriate for protection against direct contact with this material, formulation, excipients, or solvents. Consult your site safety staff for additional guidance. Eye protection: Safety glasses with side shields. Body protection: Lab coat or uniform. 9 Physical and chemical properties Form: Liquid Color: According to product specification Odor: Characteristic Value/Range Unit Method Melting point/melting range: Boiling point/boiling range: Flash point: Flammability (solid, gaseous): Density: Solubility in/miscibility with Water: 10 Stability and reactivity Not flammable. Thermal decomposition/conditions to be avoided: No decomposition is expected if used according to specifications. Dangerous reactions: No dangerous reactions known. Dangerous products of decomposition: No dangerous decomposition products known. 11 Toxicological information Acute toxicity: Lethal Dose/Lethal Concentration (LD/LC): Oxymetazoline hydrochloride Oral: LD50: 0.68 mg/kg (rat) Intraperitoneal LD50: 48 mg/kg (rat) LD50 Intravenous: 1.07 mg/kg (rat)

5 Page 5 of 6 Subcutaneous: 1.63 mg/kg (rat) Oral: LD50: >1.0 ml/kg (finished product) Eye: Slightly irritating. Subchronic to chronic toxicity: Reproductive Effects: Oxymetazoline hydrochloride Female rats given intraperitoneal dosages of 1.8 mg/kg oxymetazoline hydrochloride on days 1-3 of pregnancy experienced pre-implantation mortality. 12 Ecological information Not available. 13 Disposal considerations Recommendation: Material should be disposed of according to Schering-Plough Good Environmental Practice (GEP)#4 and/or local regulations. Incineration is the preferred disposal method. 14 Transport information Not regulated. 15 Regulations Section 313 (Specific toxic chemical listings): Some or all of the ingredients of this formulation are subject to reporting under SARA 313. TSCA (Toxic Substances Control Act): Some or all ingredients in this formulation are subject to TSCA requirements. Product related hazard information: Risk phrases: 33 Danger of cumulative effects. Safety phrases: 2 Keep out of the reach of children. 46 If swallowed, seek medical advice immediately and show this container or label.

6 Page 6 of 6 16 Other information Although reasonable care has been taken in the preparation of this document, we extend no warranties and make no representations as to the accuracy or completeness of the information contained therein, and assume no responsibility regarding the suitability of this information for the user's intended purposes or for the consequences of its use. Each individual should make a determination as to the suitability of the information for their particular purpose(s). Department issuing MSDS: Safety & Industrial Hygiene Schering-Plough Corporation 1095 Morris Avenue Union, NJ USA Schering-Plough MSDS HelpLine: (800) (US & Canada) (908) (Worldwide) Create date: 01/12/2000