Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 1 of 8
Effective Date: 2/28/02 Supersedes: 10/03/01
Section 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
?br>
Product Name: Ocuvite PreserVisionTM For Information: 1-800-553-5340
Product Code(s): AB43262, AB43208 For Emergency: 1-800-535-5053
Chemical Family: NA
Manufactured For: Bausch & Lomb, Incorporated
Address: 1400 N. Goodman Street
Rochester, New York 14603
Section 2: COMPOSITION / INFORMATION ON INGREDIENTS
OCCUPATIONAL EXPOSURE LIMITS / GUIDELINES
OSHA PEL ACGIH TLV NIOSH REL IRELAND HSE
CAS # COMPONENT NAME % W/W TWA /STEL TWA /STEL TWA /STEL TWA /STEL TWA /STEL UNITS
Tablet Core:
mg/m3
50-81-7 Ascorbic Acid, USP, 90% < 15 NE NE NE NE NE NE NE NE NE NE
mg/m3
1317-38-0 Cupric Oxide < 0.1 1 NE 1 NE 1 NE 1 2 1 NE
mg/m3
9004-34-6 Microcrystalline Cellulose NF < 20 15*5** NE 10 NE 15*5** NE 10*4** 20* 10*4** NE
mg/m3
NE Lactose Monohydrate NF < 35 NE NE NE NE NE NE NE NE NE NE
mg/m3
557-04-0 Magnesium Stearate NF <1 NE NE 10* NE NE NE NE NE NE NE
9003-39-8 Crospovidone NF < 10 NE NE NE NE NE NE NE NE NE NE NA
mg/m3
63231-67-4 Silicon Dioxide NF <1 20 mppcf 10 NE 6 NE NE NE NE NE
mg/m3
57-11-4 Stearic Acid NF <1 NE NE NE NE NE NE NE NE NE NE
NE Vitamin E Preparation USP (See Note #1) < 25 NE NE NE NE NE NE NE NE NE NE NA
7235-40-7 Beta Carotene 10% < 10 NE NE NE NE NE NE NE NE NE NE NA
mg/m3
1314-13-2 Zinc Oxide USP <5 15*5** NE 10 NE 5 C15 NE NE 5 10
TOTAL 100
Coating:
9005-65-6 Polysorbate 80 NF <1 NE NE NE NE NE NE NE NE NE NE NA
77-93-0 Triethyl Citrate < 10 NE NE NE NE NE NE NE NE NE NE NA
NE Other Non-Hazardous Ingredients > 89 NE NE NE NE NE NE NE NE NE NE NA
________
TOTAL 100 * Total Dust
** Respirable Dust
3
Note: 1-Manufacturer's recommended exposure limit 10 mg/m (8-hour time-weighted average)
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
MG/M3: Milligrams Per Cubic Meter
MPPCF: Millions of Particles Per Cubic Foot
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 2 of 8
Section 3: HAZARDS IDENTIFICATION (cont.)
EMERGENCY OVERVIEW
This product is not intended to diagnose, treat, cure or
prevent any disease. If any discomfort develops,
immediately discontinue use of this product. If
discomfort persists, contact your eye care professional.
Use only in accordance with product literature.
PRECAUTIONS:
This product is intended as a high-potency antioxidant supplement with the antioxidant vitamins A, C, E and
select minerals in amounts well above 100% of the US Government recommended daily value. This product is
not intended to diagnose, treat, cure or prevent any disease. If any discomfort develops, immediately discontinue
use of this product. If discomfort persists, contact your eye care professional. Use only in accordance with
product literature.
Smokers: Consult your eye care professional about the risks associated with smoking and using Beta-Carotene.
If you are allergic to any ingredient in this product, DO NOT USE.
POTENTIAL HEALTH EFFECTS
EYE:
Tablet dust may be irritating to the eyes.
SKIN:
Non-irritating to skin or mucous membranes when used as directed.
INGESTION:
No hazard when used as directed.
INHALATION:
No hazard when used as directed.
CHRONIC HEALTH EFFECTS
No known chronic hazards.
CARCINOGENICITY:
NTP: No ingredients listed.
IARC: CAS 9003-39-8 (Not classifiable as to its carcinogenicity to humans)
OSHA: No ingredients listed.
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 3 of 8
Section 4: FIRST AID MEASURES
EYES:
Immediately flush eyes with plenty of water for at least 15 minutes. If any discomfort develops, get medical attention
immediately.
SKIN:
No specific treatment is necessary since this material is not hazardous by contact with the skin or mucous membranes.
INGESTION:
No specific treatment is necessary since this material is not hazardous by ingestion when used in accordance with
product literature. If quantities exceeding the recommended intake are accidentally ingested, get medical attention
immediately.
INHALATION:
If exposed to excessive levels of dusts, remove to fresh air and get medical attention if cough or other symptoms develop.
Section 5: FIRE FIGHTING MEASURES
FLAMMABLE PROPERTIES:
Flash Point: Non-Combustible
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:
Contain spill and place in a chemical waste container. Dispose of in accordance with Section 13.
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 4 of 8
Section 7: HANDLING AND STORAGE
HANDLING:
No special handling is required. Use in accordance with product literature.
STORAGE:
Store at room temperature to maintain product integrity.
Section 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
RESPIRATORY PROTECTION:
No special controls or personal protection required under conditions of intended use.
SKIN PROTECTION:
No special controls or personal protection required under conditions of intended use.
EYE PROTECTION:
No special controls or personal protection required under conditions of intended use.
ADDITIONAL PROTECTIVE CLOTHING & EQUIPMENT:
NA
Section 9: PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL PROPERTIES:
Appearance / Physical State: Oval shaped, plain orange tablet embossed with "BL 01" on one side,
bisected on the other side
Odor: Odorless
CHEMICAL PROPERTIES:
Boiling Point: Not Determined Melting Point: Not Applicable
Vapor Pressure: Not Determined Vapor Density: Not Determined
Solubility In Water: Soluble Specific Gravity (H2O = 1): Not Applicable
pH: Not Applicable Freezing Point: Not Determined
Molecular Weight: Mixture, Not Applicable
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 5 of 8
Section 10: STABILITY AND REACTIVITY
GENERAL:
Stable under normal conditions.
INCOMPATIBLE MATERIALS AND CONDITIONS TO AVOID:
None.
HAZARDOUS POLYMERIZATION:
Will not occur.
HAZARDOUS DECOMPOSITION:
None identified.
Section 11: TOXICOLOGICAL INFORMATION
RTECS No.: CI7650000
Ascorbic Acid
Toxicity Data: ORL-RAT LD50: 11,900 MG/KG
IP-MOUSE LD50: 6,600 MG/KG
RTECS No.: GL7900000
Cupric Oxide
Toxicity Data: INTRATRACHEAL-RAT LDLo: 278 MG/KG
RTECS No.: FJ5691460
Microcrystalline Cellulose NF
Toxicity Data: ORL-RAT LD50: >5 GM/KG
RTECS No.: OD9625000
Lactose Monohydrate NF
Toxicity Data: ORL-RAT LD50: >10 GM/KG
RTECS No.: WI4390000
Magnesium Stearate NF
Toxicity Data: ORL-RAT TDLo: 1,092 GM/KG/13W-C
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 6 of 8
Section 11: TOXICOLOGICAL INFORMATION (cont.)
RTECS No.: TR8160000
Crospovidone NF
Toxicity Data: ORL-MOUSE LDLo: 3 GM/KG
RTECS No.: VV7340000
Silicon Dioxide NF
Toxicity Data: ORL-RAT LD50: 4,500 MG/KG*
RTECS No.: WI2800000
Stearic Acid NF
Toxicity Data: ORL-RAT LDLo: 4,640 MG/KG
RTECS No.: GA8747000
dl-Alpha-Tocopherol Acetate
Toxicity Data: ORL-RAT LD50: >16,000 MG/KG*
RTECS No.: FI0329500
Beta Carotene
Toxicity Data: ORL LD50: >5,000 MG/KG*
RTECS No.: ZH4810000
Zinc Oxide USP
Toxicity Data: ORL-RAT LD: >8,437 MG/KG
RTECS No.: WG2932500
Polysorbate 80 NF
Toxicity Data: ORL-RAT LD50: 34,500 UL/KG
RTECS No.: GE8050000
Triethyl Citrate
Toxicity Data: ORL-RAT LD50: 5900 MG/KG
NOTE: Only selected Registry of Toxic Effects of Chemical Substances (RTECS) data is presented
here. See actual entry in RTECS for complete information.
(*) Toxicological data supplied by the manufacturer.
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 7 of 8
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.
Section 15: REGULATORY INFORMATION
OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200):
?br>
Ocuvite PreserVisionTM is considered non-hazardous under the Occupational Safety & Health Administration Hazard
Communication Standard.
TOXIC SUBSTANCE CONTROL ACT (TSCA):
All ingredients are 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 which would require a warning under the statute.
Ocuvite?PreserVisionTM
MATERIAL SAFETY DATA SHEET
Page 8 of 8
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.
|