===================== Product Identification =====================
MSDS NAME:EMLA 5% CREAM
NIIN:01-385-0530
MSDS Number: BWXYN
=== Responsible Party ===
Company:ASTRA PHARMACEUTICAL PRODUCTS INC
Address:50 OTIS ST
City:WESTBOROUGH
State:MA
ZIP:01581-3323
Country:US
Info Phone Num:508-366-1100/800-225-6333
Emergency Phone Num:800-225-6333/508-366-1100
CAGE:04473
=== Contractor Identification ===
Company:ASTRA PHARMACEUTICAL PRODUCTS INC
Address:50 OTIS ST
Box:City:WESTBOROUGH
State:MA
ZIP:01581-3323
Country:US
Phone:508-366-1100/800-225-6333
CAGE:04473
============= Composition/Information on Ingredients =============
Name:LIDOCAINE HYDROCHLORIDE
CAS:73-78-9
RTECS #:AN7600000
Fraction by Wt: 2.5%
Name:PRILOCAINE HYDROCHLORIDE
CAS:1786-81-8
RTECS #:UG5775000
Fraction by Wt: 2.5%
Name:ARLATONE 289
Fraction by Wt: 1.9%
Name:CARBOMER 934, CARBOPOL 934
CAS:9007-16-3
RTECS #:AT4683000
Fraction by Wt: 1%
Name:SODIUM HYDROXIDE, CAUSTIC SODA, LYE
CAS:1310-73-2
RTECS #:WB4900000
Fraction by Wt: <1%
Other REC Limits:2MG/M3 CEILING NIOSH
OSHA PEL:2 MG/CUM
ACGIH TLV:2 MG/CUM CEILING
EPA Rpt Qty:1000 LBS
DOT Rpt Qty:1000 LBS
===================== Hazards Identification =====================
LD50 LC50 Mixture:ORAL LD50(RATS): 220 MG/KG LIDOCAINE
Routes of Entry: Inhalation:NO Skin:YES Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO
Health Hazards Acute and Chronic:SKIN: PROLONGED CONTACT MAY LEAD TO
CNS & CARDIOVASCULAR EFFECTS; SEVERE SHOCK & HEART BLOCK.
INDIVIDUALS WHO ARE HYPERSENSITIVE TO AMIDE-TYPE LOCAL ANESTHETICS
CAN EXPERIENCE ALLERGIC REACTIONS TO EM LA CREAM. EYES: CAN LEAD TO
REVERSIBLE CORNEAL IRRITATION. IRRITANT TO TOXIC CHEMICAL.
Explanation of Carcinogenicity:NONE
Effects of Overexposure:SHOCK, IRRITATION, DROWSINESS, EXCITATION,
DEPRESSION, LIGHT-HEADEDNESS, NERVOUSNESS, EUPHORIA, BLURRED
VISION, TREMORS, CONVULSIONS, BRADYCARDIA, HYPOTENSION, CARDIAC
ARREST, CUTANEOUS LESIONS, EDEMA , UTICARIA, ANAPHYLAXIS, CYANOSIS
Medical Cond Aggravated by Exposure:IMPAIRED CARDIOVASCULAR FUNCTION;
HEPATIC & RENAL DISORDERS; HYPERSENSITIVITY TO AMIDE-TYPE LOCAL
ANESTHETICS; USE OF ANTIARRHYTHMIC DRUGS, STIMULANTS & DEPRESSANTS;
ACIDOSIS; EARLY PREGNANCY.
======================= First Aid Measures =======================
First Aid:SKIN: WIPE OFF & WASH IMMEDIATELY. EYES: FLUSH THOROUGHLY
W/WATER. MONITOR CAREFULLY FOR CNS & CVS, MAINTAIN RESPIRATION &
HEARTBEAT IF NECESSARY. OBTAIN MEDICAL ATTENTION IN ALL CASES.
===================== Fire Fighting Measures =====================
Flash Point:NON-FLAMMABLE
Extinguishing Media:WATER, DRY CHEMICAL, CO2/FOAM AS APPROPRIATE FOR
SURROUNDING MATERIALS
Fire Fighting Procedures:USE SELF CONTAINED BREATHING APPARATUS &
PROTECTIVE CLOTHING.
Unusual Fire/Explosion Hazard:TOXIC FUMES CAN BE PRODUCED IN A FIRE.
================== Accidental Release Measures ==================
Spill Release Procedures:WEAR GLOVES TO CLEAN UP MATERIAL. USE INERT
MATERIALS TO WIPE UP CREAM. PLACE IN PLASTIC BAG, SEAL & DISPOSE OF
APPROPRIATELY.
====================== Handling and Storage ======================
Handling and Storage Precautions:KEEP CONTAINER TIGHTLY CLOSED WHENEVER
NOT IN USE. STORE AT CONTROLLED ROOM TEMPERATURE, 59F-86F.
Other Precautions:AVOID CONTACT W/EYES & SKIN. AVOID INGESTION.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:NONE NECESSARY
Ventilation:LOCAL EXHAUST
Protective Gloves:PROTECTIVE
Eye Protection:REQUIRED
Other Protective Equipment:GOWN/COVERALLS
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING BEFORE
REUSE. IF IN CONTACT, WIPE OFF EXCESS CREAM THEN WASH THOROUGHLY.
Supplemental Safety and Health
PHARMACEUTICAL PRODUCT FOR USE AS A TOPICAL ANESTHETIC.
================== Physical/Chemical Properties ==================
Melt/Freeze Pt:M.P/F.P Text:64.4F
Solubility in Water:COMPLETE
Appearance and Odor:WHITE, SOFT, HYDROPHILIC, HOMOGENEOUS CREAM
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
NONE
Stability Condition to Avoid:TEMP >59F.
Hazardous Decomposition Products:TOXIC FUMES
==================== Disposal Considerations ====================
Waste Disposal Methods:DISPOSE OF BY INCINERATION/IN ACCORDANCE
W/LOCAL, STATE & FEDERAL REGULATIONS.
Disclaimer (provided with this information by the compiling agencies):
This information is formulated for use by elements of the Department
of Defense. The United States of America in no manner whatsoever,
expressly or implied, warrants this information to be accurate and
disclaims all liability for its use. Any person utilizing this
document should seek competent professional advice to verify and
assume responsibility for the suitability of this information to their
particular situation.
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