MATERIAL SAFETY DATA SHEET MSDS# 3007.1
WHILE WE BELIEVE THE INFORMATION PROVIDED HEREIN IS ACCURATE AND CURRENT, WARNER-LAMBERT COMPANY
MAKES NO REPRESENTATIONS OR
WARRANTIES, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITY FOR ANY DAMAGE OR INJURIES OF
ANY KIND WHICH MAY RESULT
FROM USE OR RELIANCE UPON THIS INFORMATION.
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SECTION I MATERIAL IDENTIFICATION
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PRODUCT NAME: DILANTIN_-125 SUSPENSION
FORMULA: MIXTURE DATE OF ISSUE: 04/14/93
NDC #: 00712214 SUPERSEDES: 03/22/91
SYNONYMS: DILANTIN_ - 125 SUSPENSION (125MG/5ML) REVISION #: 03
MANUFACTURING DIVISION ADDRESS PERSON TO CONTACT
PHONE #
201 TABOR ROAD
PARKE-DAVIS MORRIS PLAINS, NJ 07950 DAVID RHODES
(201) 540-2000
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SECTION II INGREDIENT(S)
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EXPOSURE LIMITS/GUIDELINES
LISTED AS
CAS # INGREDIENT NAME
CARCINOGEN
OSHA PEL ACGIH TLV OTHER
**
57-41-0 PHENYTOIN, USP ND ND
0.4MG/M3 YES
64-17-5 ETHYL ALCOHOL, USP (< 1%) 1000 PPM 1000 PPM
ND NO
56-81-5 GLYCERIN *10 MG/M3 *15 MG/M3
ND NO
**REFERS TO WARNER-LAMBERT OCCUPATIONAL EXPOSURE GUIDELINE
*REFERS TO EXPOSURE LIMITS FOR GLYCERIN MIST
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SECTION III PHYSICAL AND CHEMICAL DATA
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PHYSICAL STATE: LIQUID APPEARANCE: OPAQUE RED SUSPENSION
CHARACTERISTIC ODOR: BANANA-ORANGE-
VANILLA ODOR
SPECIFIC GRAVITY: 1.100 TO 1.112 SOLUBILITY:
(H2O=1) WATER: ND OTHER: ND
PH (@ 25OC): 4.7 TO 4.9
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SECTION IV FIRE AND EXPLOSION DATA
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FLASH POINT AND METHOD: ND
EXTINGUISHING MEDIUM: CO2, DRY CHEM, FOAM, WATER SPRAY
SPECIAL FIRE FIGHTING PROCEDURES: USE APPROVED SELF-CONTAINED BREATHING APPARATUS.
HAZARDOUS DECOMPOSITION OR COMBUSTION PRODUCTS: OXIDES OF CARBON AND NITROGEN
FIRE HAZARDS: ND EXPLOSION
HAZARDS: NA
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SECTION V CHEMICAL REACTIVITY DATA
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UNDER LABELED STORAGE CONDITIONS, THIS PRODUCT IS STABLE AND HAZARDOUS POLYMERIZATION SHOULD NOT
OCCUR.
NA - NOT APPLICABLE ND - NO DATA FOUND
DATE OF ISSUE: 04/14/93 MSDS# 3007.1
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SECTION VI HEALTH HAZARD INFORMATION
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TOXICITY INFORMATION: THIS INFORMATION PERTAINS TO THE FOLLOWING INGREDIENTS INDIVIDUALLY AND NOT
TO THE PRODUCT AS
MARKETED. INCLUDED WILL BE ANY DATA WHICH EMPHASIZE THE POTENTIAL EFFECTS THAT MAY OCCUR WITH THE
OCCUPATIONAL HANDLING (BY INHALATION OR BY DERMAL OR OCULAR CONTACT) OF THIS PRODUCT.
PHENYTOIN- RAT ORAL LD50: 2195 MG/KG; MOUSE ORAL LD50: 150 MG/KG; FETAL MALFORMATIONS (CLEFT
LIP/PALATE, SKELETAL
DEFECTS, REDUCED FETAL WEIGHT, CARDIOVASCULAR DEFECTS) IN MICE AND RATS ADMINISTERED PHENYTOIN
(S.C.,I.P.,P.O) DURING
PREGNANCY. IN SEVERAL STUDIES, STATISTICAL SIGNIFICANCE WAS SEEN ONLY AT MATERNALLY TOXIC DOSES. A
NUMBER OF REPORTS
SUGGEST AN ASSOCIATION BETWEEN THE USE OF ANTIEPILEPTIC DRUGS (INCLUDING DILANTIN) AND BIRTH
DEFECTS. THESE CANNOT BE
REGARDED AS ADEQUATE TO PROVE A DEFINITE CAUSE AND EFFECT RELATIONSHIP. FETAL MALFORMATIONS HAVE
BEEN REPORTED IN PREGNANT
WOMEN BEING TREATED CLINICALLY. ADVERSE REACTIONS IN PATIENTS MOST COMMONLY ASSOCIATED WITH
PHENYTOIN THERAPY ARE
RELATED TO THE CNS AND INCLUDE NYSTAGMUS (RAPID EYE MOVEMENT), ATAXIA, SLURRED SPEECH, DROWSINESS,
DECREASED COORDINATION,
AND MENTAL CONFUSION. NOT MUTAGENIC IN BACTERIA, OR GENOTOXIC IN ANIMALS OR HUMAN CELLS IN VITRO.
WORKERS HANDLING BULK
PHENYTOIN AND PHENYTOIN SODIUM POWDERS HAVE REPORTED PHARYNGEAL IRRITATION.
ETHYL ALCOHOL- RAT ORAL LD50: 7.06 G/KG; RAT INHALATION LCLO: 20,000 PPM/10 HOURS; RABBIT DERMAL
LDLO: 20 G/KG; IN HUMANS,
EXPOSURE TO 5,000-10,000 PPM RESULTED IN EYE AND MUCOUS MEMBRANE IRRITATION. EXPOSURES OVER 1000
PPM MAY CAUSE HEADACHE,
IRRITATION OF EYES, NOSE AND THROAT AND IF LONG CONTINUED, DROWSINESS, LASSITUDE, LOSS OF APPETITE
AND INABILITY TO
CONCENTRATE. AT CONCENTRATIONS ABOVE 5,000 PPM; EYE AND UPPER RESPIRATORY TRACT IRRITATION, STUPOR,
FATIGUE, AND SLEEPINESS
MAY OCCUR.
GLYCERIN- RAT ORAL LD50: 12.6 G/KG; MOUSE ORAL LD50: 4 G/KG; MILD SKIN AND EYE IRRITANT IN RABBIT
STUDIES.
(REFER TO CURRENT PACKAGE INSERT FOR FURTHER INFORMATION)
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SECTION VII FIRST AID INFORMATION
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THERAPEUTIC CLASS: ANTICONVULSANT, ANTIEPILEPTIC
EYES: FLUSH WITH WATER FOR 15 MINUTES; IF IRRITATION SKIN: WASH WITH SOAP AND WATER UNTIL FREE
OF RESIDUE.
PERSISTS, GET MEDICAL HELP.
INHALATION: REMOVE TO FRESH AIR; SEEK MEDICAL ATTENTION. INGESTION: FOR OVERDOSE, SEEK MEDICAL
ATTENTION;
_ FOR ADDITIONAL FIRST AID INFORMATION CALL: (201) 540-2000
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SECTION VIII SPECIAL PROTECTION INFORMATION
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MATERIAL SHOULD BE HANDLED IN SUCH A WAY AS TO AVOID SKIN AND EYE CONTACT. SHOULD CONTACT OCCUR,
WASH EXPOSED SKIN
PROMPTLY. LAUNDER CONTAMINATED CLOTHING AND WASH CONTAMINATED EQUIPMENT BEFORE REUSE.
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SECTION IX SPILL, LEAK, AND DISPOSAL PROCEDURES
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ACTION TO BE TAKEN IF MATERIAL IS RELEASED OR SPILLED:
WIPE OR MOP UP SPILLED MATERIAL. WASH ALL CONTAMINATED SURFACES WITH SOAP AND WATER. PLACE WASTE
IN APPROPRIATE
CONTAINER FOR FUTURE DISPOSAL.
WASTE DISPOSAL METHOD:
DISPOSE OF IN ACCORDANCE WITH LOCAL, STATE AND FEDERAL REGULATIONS OR THE AUTHORITY HAVING
JURISDICTION.
INCINERATION IN A PERMITTED INCINERATOR IS THE PREFERRED DISPOSAL METHOD.
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SECTION X SPECIAL PRECAUTIONS
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STORE AS STATED IN PRODUCT LABELING.
SHIPPING REQUIREMENTS AND LIMITATIONS
PROPER SHIPPING NAME: NON-REGULATED ID/UN NUMBER: NA
CONTAINER SPECIFICATION: NA
HAZARD CLASS: NA LABEL: NA
PACKAGING GROUP: NA
SHIPPING LIMITATIONS: NA MARKING: NA OTHER
COMMENTS: NA
NA- NOT APPLICABLE ND- NO DATA FOUND
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