Oxymetazoline Hydrochloride 2315-02-8 0 .0251
Water
Boric- Acid 10043-35- 3 -
Sodium Chloride 7647-14-5 -
Edetate Disodium 139-33-3 -
1303-96-4 -
Sodium Borate
Benzalkonium Chloride 8001-54-5 -
2. EMERGENCY OVERVIEW
Emergency and
First Aid Procedures
ingestion : Because potential sedation from Visine Long Lasting Eye Drops could ,
result in the patient aspirating vomitus, vomiting is not recommended . Keep patient warm .
Commercially prepared charcoal suspension or activated charcoal slurry may be given : (30 gm
charcoal per 240 ml of water or saline cathartic or sorbitol) (Adult dose : 30-100 gm of
activated charcoal - Children dose : 15-30 gm of activated charcoal) . Treatment should be
supportive and symptomatic . Seek medical attention if any signs of excessive sedation
occur, especially with infants or children .
Skin Contact : Remove contaminated clothing and wash skin thoroughly with mild soap and
water . Seek the advice of a Health Professional if irritation continues or if symptoms of
borate toxicity occur .
1%estionN T : G erally, adverse effects reported to Pfizer in cases of
'(Nut pout;of
accidental ingestion have been sedation and reduction of body temperature . Effects include
very rapid onset of drowsiness in children . Even small amounts in children may cause
agitation, mild coma, bradycardia and decreased respiration . Other effects in adults may
include nausea, headache, dizziness, lightheadedness, nervousness, irritability, insomnia,
hypertension, cardiac palpitation and cardiac arrhythmias .
Skin Contact, : Symptoms of sodium borate and boric acid toxicity might result after
ingestion or through skin or mucous membrane absorption . Symptoms include vomiting,
diarrhea, skin and mucous membrane eruptions . Higher doses produce tachycardia,
circulatory collapse, cyanosis, delirium, convulsions and coma . Fatalities have occurred
from ooen wound absorotion of boric acid .
-051 (4/92)
FORM
4 . SPILL . LEAK AND DISPOSAL PROCEDURES
Accidental Release Measures
Remove sources of heat or ignition .
Notify safety personnel of leaks or spills .
Provide adequate ventilation . Cover spills with inert, noncombustible absorbent
material and remove to disposal container .
Waste Disposal Method
Waste material should be handled in accordance with Federal, State and Local
Environmental Regulations via a licensed waste disposal company .
5. HANDLING AND STORAGE CONDITIONS
- 86'F)
Store between 2 and 30掳C (36
6 . REGULATORY INFORMATION
Labeled in accordance with the Federal Food, Drug and Cosmetic Act .
FORM
5CO10-052 (4/92)
Personal Protection
Skin Eyes
Standard precautions None required
Other
None required
Respiratory Requirements
None required
8 . PHYSICAL DATA
Soiling Point, 760 mm Hg : Freezing Point, 760 mm Hg : % Volatlles Evaporation Pate
Not Available Not Available Not Available
掳C
Not Available 掳C
Solubility In water,
Specific Gravity (H2O= 1)
% by wt. at 20掳C:
25 掳 /25掳C :0 .998-1 .017 Miscible _
Vapor Pressure at 20掳C Vapor Density (Air= 1)
pH at 25 掳 C (as Is)
Not Available Not Available
6 .30 - 6 .50
Description
A clear, colorless, isotonic, buffered, sterile solution
9 . STABILITY AND REACTIVITY DATA
Conditions to Avoid
Stability
X
None Known
Unstable Stable
Avoid strong oxidizing and reducing agents,
Incompatibility :
(Materials to avoid) acetic anhydride and elemental potassium and zirconium
Carbon and nitroqen oxides
Hazardous Decomposition
Products : Hydrogen, chlorine and ammonium fumes
Conditions to Avoid
Hazardous Polymerization
X Will Not Occur None Known
May Occur
FORM 5C010-053 (4/92)
11 . TOXICOLOGY INFORMATION
Ingestion : 2 .45(1 .81-3 .31)g/kg-LD50 -rat-oral-not identified as a developmental
toxin-rabbits
Eye Contact : 28 day study-human-safe in twice daily use ;
28 day study-human-safe in thrice daily use ;
multiple dose-rabbit-no irritation
The estimated fatal dose of oxymetazoline for children up to 2 years of age is 10 mg
intranasally, and the fatal dose of boric acid or sodium borate is 0 .1 to 0 .5 g/kg
(Handbook of Poisoning, 12th Edition, 1987) . Each one fluid ounce bottle of
Visine L . R . contains approximately 7 .5 mg . of oxymetazoline llC1, 369 mg of boric acid
and 15 mg of sodium borate . Oxymetazoline is poorly absorbed into the eye and has few
systemic effects when properly instilled in the eye (Arch . Opth .,, 100, July 1983) .
REVISIONS
12.
01/04/93 change to new format
new toxicology data
03/16/94 change of product name
13 . REFERENCES
Pfizer Product Files, Consumer Health Care Division, Parsippany, NJ ;
Guide to Occupational Exposure Values, ACGIH, 1991-2 ; MSDS Handbook, 1985, OHS, Inc . ;
A .C . Bronstein & P .L . Currance, Emergency Care for Hazardous Materials Exposure, 1988 ;
MSDS of Raw Materials
ss/663
Legal responsibility Is assumed only for the fact that all studier reported here and all opinions are those of qualified experts .
FORM 5C01O-054 (4/92)
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