Alaway鈩?
MATERIAL SAFETY DATA SHEET
Page 1 of 6
Effective Date: 1/31/07 Supersedes: None
Section 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: Alaway鈩? For Information: 1-800-553-5340
Product Code(s): 622227 For Emergency: 1-800-535-5053
Chemical Family: Not Applicable
Manufacturer: Bausch & Lomb, Incorporated
Address: 1400 N. Goodman Street
Rochester, New York 14609
Section 2: COMPOSITION / INFORMATION ON INGREDIENTS
OCCUPATIONAL EXPOSURE LIMITS / GUIDELINES
OSHA PEL ACGIH TLV NIOSH REL IRELAND HSE
CAS # COMPONENT NAME % W/W UNITS
TWA /STEL TWA /STEL TWA /STEL TWA /STEL TWA /STEL
Active(s):
34580-14-8 Ketotifen Fumarate 0.035 NE NE NE NE NE NE NE NE NE NE NA
Inactive(s):
8001-54-5 Benzalkonium Chloride 0.01 NE NE NE NE NE NE NE NE NE NE NA
56-81-5 Glycerine < 10 15*5** NE 10 NE NE NE 10 NE 10 NE MG/M3
7732-18-5 Purified Water Bal. NE NE NE NE NE NE NE NE NE NE NA
_______
TOTAL 100***
N/E: Not Established OSHA: Occupational Safety & Health Administration TWA: 8-Hour Time-Weighted Average
N/A: Not Applicable PPM: Parts Per Million STEL: Short-Term Exposure Limit
ACGIH: American Conference of Governmental Industrial Hygienists C: Ceiling Limit
NIOSH: National Institute for Occupational Safety & Health REL: Recommended Exposure Limit
* Total Mist
** Respirable Mist
*** pH balanced with sodium hydroxide and/or hydrochloric acid
Section 3: HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
This product is intended for the temporary relief of itchy eyes
due to ragweed, pollen, grass, animal hair and dander. Do
Not Use: if you are sensitive to any ingredient in this product,
if the solution changes color or becomes cloudy, or to treat
contact lens related irritation. Keep out of reach of children.
Alaway鈩?
MATERIAL SAFETY DATA SHEET
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Section 3: HAZARDS IDENTIFICATION (cont.)
PRECAUTIONS:
This product is intended for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and
dander. Do Not Use: if you are sensitive to any ingredient in this product, if the solution changes color or
becomes cloudy, or to treat contact lens related irritation.
Use in accordance with product literature and Drug Facts information.
Keep out of reach of children.
POTENTIAL HEALTH EFFECTS
EYE:
Non-irritating to the eyes when used as directed.
SKIN:
Non-irritating to skin or mucous membranes when used as directed.
INGESTION:
May be harmful if swallowed.
INHALATION:
Unlikely to be hazardous when used as directed.
CHRONIC HEALTH EFFECTS
No known chronic hazards.
CARCINOGENICITY:
NTP: No ingredients listed.
IARC: No ingredients listed.
OSHA: No ingredients listed.
Section 4: FIRST AID MEASURES
EYES:
If discomfort or irritation develops, immediately discontinue product use and contact your eye care professional. Flush
with running water for at least 15 minutes.
SKIN:
Wash contaminated area with soap and water.
Alaway鈩?
MATERIAL SAFETY DATA SHEET
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Section 4: FIRST AID MEASURES (cont.)
INGESTION:
Seek medical attention immediately and provide Drug Facts information.
INHALATION:
No specific treatment is necessary since this material is not likely to be hazardous by inhalation. If exposed to excessive
levels of mists, remove to fresh air and get medical attention if cough or other symptoms develop.
Section 5: FIRE FIGHTING MEASURES
FLAMMABLE PROPERTIES:
Flash Point: Not Available
Method: NA
EXTINGUISHING MEDIA:
Water spray, carbon dioxide, dry chemical powder or appropriate foam for surrounding fire.
HAZARDOUS COMBUSTION PRODUCTS:
None identified.
SPECIAL FIRE FIGHTING INSTRUCTIONS:
As in any fire, wear self-contained breathing apparatus and full protective gear.
Section 6: ACCIDENTAL RELEASE MEASURES
General Information:
Using appropriate protective equipment, wipe up spilled material with disposable towels and place in a chemical waste
container. Dispose of in accordance with Section 13.
Section 7: HANDLING AND STORAGE
HANDLING:
No special handling is required. Use in accordance with product literature.
STORAGE:
Store product at 4掳 - 25掳C (39掳 - 77掳F)
Shelf Life: Expiration date is listed on each package.
Alaway鈩?
MATERIAL SAFETY DATA SHEET
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Section 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
RESPIRATORY PROTECTION:
Not required during normal clinical use.
SKIN PROTECTION:
Not required during normal clinical use.
EYE PROTECTION:
Not required during normal clinical use.
ADDITIONAL PROTECTIVE CLOTHING & EQUIPMENT:
None
Section 9: PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL PROPERTIES:
Appearance / Physical State: Clear, colorless to light yellow liquid
Odor: None
CHEMICAL PROPERTIES:
Boiling Point: Not Available Melting Point: Not Applicable
Vapor Pressure: Not Available Vapor Density: Not Available
鈭? 1.0
Solubility In Water: Not Available Specific Gravity (H2O = 1):
pH: 4.4 鈥? 6.0 Freezing Point: Not Available
Molecular Weight: 425.5 Evaporation Rate: Not Available
Section 10: STABILITY AND REACTIVITY
GENERAL:
Stable under normal conditions.
INCOMPATIBLE MATERIALS AND CONDITIONS TO AVOID:
Not Available.
HAZARDOUS POLYMERIZATION:
Will not occur.
HAZARDOUS DECOMPOSITION:
None identified.
Alaway鈩?
MATERIAL SAFETY DATA SHEET
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Section 11: TOXICOLOGICAL INFORMATION
RTECS No.: DE8250000
Ketotifen Fumarate
ORL-RAT LD50: 360 MG/KG
Toxicity Data:
RTECS No.: BO3150000
Benzalkonium Chloride
ORL-RAT LD50: 50-500 MG/KG
Toxicity Data:
RTECS No.: MA8050000
Glycerine
ORL-RAT LD50: 12600 MG/KG
Toxicity Data:
NOTE: Only selected Registry of Toxic Effects of Chemical Substances (RTECS) data is presented
here. See actual entry in RTECS for complete information.
Section 12: ECOLOGICAL INFORMATION
No data available on the environmental impact of this product.
Section 13: DISPOSAL CONSIDERATIONS
All disposal methods must be in compliance with all Federal, State/Provincial and local laws and regulations. Regulations
may vary in different locations. Waste characterizations and compliance with applicable laws are the responsibility solely
of the waste generator.
Section 14: TRANSPORT INFORMATION
US DOT IATA IMO RID/ADR Canadian DG
No Information No Information No Information
Shipping Name: Not Regulated Not Regulated
Available Available Available
Hazard Class: NA NA
UN Number: NA NA
Package Group: NA NA
There are no unreasonable risks (health, safety, or property), that this product would pose when transported in
commerce. Hazard class definitions (49 CFR, Part 173) are not applicable to this product.
Alaway鈩?
MATERIAL SAFETY DATA SHEET
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Section 15: REGULATORY INFORMATION
OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200):
This product is considered hazardous under the Occupational Safety & Health Administration Hazard Communication
Standard.
TOXIC SUBSTANCE CONTROL ACT (TSCA):
CAS# 8001-54-5 is listed on the TSCA inventory.
CAS# 56-81-5 is listed on the TSCA inventory.
CAS# 7732-18-5 is listed on the TSCA inventory.
SARA TITLE III (Superfund Amendments and Reauthorization Act):
SECTION 302 (Extremely Hazardous Substances): No Components Listed
SECTION 311, 312 (Hazard Categories): NA
SECTION 313 (Toxic Chemicals): No Components Listed
CALIFORNIA PROPOSITION 65:
This product contains no listed substances known to the State of California to cause cancer, birth defects or other
reproductive harm, at levels that would require a warning under the statute.
Section 16: OTHER INFORMATION
To the best of our knowledge, the information contained herein is accurate. However, neither Bausch & Lomb
Incorporated 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. NO WARRANTY, EXPRESS OR IMPLIED, OF
MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Bausch & Lomb Incorporated or any of its
subsidiaries be liable for any special, incidental or consequential damages.
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