Material Safety Data Sheet
MSDS Number: 1102387
Revision date: 11/12/2003
Print date: 11/13/2003
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
MSDS Number: 1102387
Product name: Diphenhydramine Hydrochloride Injection, USP
Product code: NDC 0641-0376-25, NDC 0641-0376-21
Synonyms: None
Chemical Family: Antihistaminic Agent.
Product Type: Regulated Prescription Drug
Container Information: 1 ml dosette?vials
Product Use: Pharmaceutical
Supplier:
BAXTER HEALTHCARE CORPORATION
DEERFIELD, ILLINOIS 60015
(800) 422-9837 or (847) 948-4770
Emergency telephone number: PROSAR: USA (888) 990-0996 OUTSIDE USA (615)917-6114
CHEMTREC: USA (800) 424-9300 OUTSIDE USA (743)741-6089
2. COMPOSITION/INFORMATION ON INGREDIENTS
Component Weight % UN Number: Classification:
Diphenhydramine hydrochloride 5 None T
147-24-0
Benzethonium chloride <0.05 None None
121-54-0
Water >94 None None
7732-18-5
3. HAZARDS IDENTIFICATION
Emergency overview: Warning! Harmful if swallowed. Do not ingest. Central Nervous System
depression.
Principle routes of exposure: Absorbed through skin. Eye contact. Ingestion.
Inhalation: Inhalation not likely under normal use conditions.
Ingestion: Harmful if swallowed. Gastrointestinal effects. Nervous system effects (may
include drowsiness, confusion, hallucinations, convulsions, visual disturbances,
headache, coma).
Skin contact: No known effect according to our database.
Eye contact: No known effect according to our database.
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
4. FIRST AID MEASURES
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If
breathing is difficult, give oxygen. Seek medical attention.
Skin contact: Wash contaminated skin with soap and water. Get medical attention if irritation
develops.
Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never
give anything by mouth to an unconscious person. If large quantities of this
material are swallowed, call a physician immediately.
Eye contact: In case of contact, immediately flush eyes with plenty of water for at least 15
minutes. Get medical attention if irritation develops.
Notes to physician: See patient package insert in shipping carton for complete information.
5. FIRE FIGHTING MEASURES
Suitable extinguishing media: Use foam or all purpose dry chemicals to extinguish.
Special protective equipment for firefighters: Fire fighters should wear positive pressure self-contained
breathing apparatus (SCBA) and full turnout gear.
Specific methods: No information available.
Flash point: Not determined
Autoignition temperature: Not applicable
Flammable limits in air-lower (%): Not applicable
Flammable limits in air-upper (%): Not applicable
6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Keep unnecessary personnel away. Use suitable protective equipment (Section
8). Follow all fire fighting procedures (Section 5).
Environmental precautions: No information available.
Methods for cleaning up: If emergency personnel are unavailable, contain spilled material. For small spills
add absorbent (soil may be used in the absence of other suitable materials) scoop
up material and place in a sealed, liquid-proof container for disposal. For large
spills dike spilled material or otherwise contain material to ensure runoff does not
reach a waterway. Place spilled material in an appropriate container for disposal.
7. HANDLING AND STORAGE
Handling:
Technical Wash thoroughly after handling.
measures/precautions:
Storage:
Technical measures/storage Keep containers tightly closed in a cool, well-ventilated place. Keep at
conditions: temperatures between 15 and 30 癈 (59 to 86癋).
Incompatible products: No special restrictions on storage with other products.
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Occupational Exposure Limits
Component OSHA- Time OSHA- Short OSHA- Ceiling ACGIH- Time ACGIH- Short ACGIH- Ceiling
Weighted Term Limits Weighted Term Limit Value:
Average: Exposure Average: Exposure
Limit: Limit:
Diphenhydramine hydrochloride None None None None None None
147-24-0
Benzethonium chloride None None None None None None
121-54-0
Water None None None None None None
7732-18-5
Engineering measures: No special containment is required. Good general ventilation should be sufficient
to control airborne levels.
Personal protective equipment:
Respiratory protection: Perform exposure monitoring for this product and its components to ensure that
employees are not exposed to levels greater than applicable regulatory limits. If
exposure levels exceed regulatory limits, implement a respiratory protection
program including respiratory protection that is in compliance with OSHA 29
CFR1910.134 (in the US) or equivalent regulation in other regions. Fire fighting
requires the use of a self-contained breathing apparatus with full face piece and
positive pressure mode.
Hand protection: Use chemical resistant, impervious gloves.
Skin and body protection: Work uniform or laboratory coat.
Eye protection: Safety glasses. Goggles, face shield, or other full-face protection if potential exists
for direct exposure to aerosols or splashes.
9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state: Liquid
Appearance: Aqueous solution
Color: Colorless
Odor: Not available.
pH: 4.0 - 6.5
Molecular weight: Not available.
Boiling point/range: Not available.
Melting point/range: Not available.
Density: Not available.
Vapor pressure: Not available.
Evaporation rate: Not available.
Solubility: Not available.
Partition coefficient (n- Not available.
octanol/water):
Viscosity: Not available.
% Volatile by Volume: Not available.
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions.
Polymerization: Not applicable
Hazardous decomposition Not available.
products:
Materials to avoid: Acids. Bases. Oxidizing agents.
11. TOXICOLOGICAL INFORMATION
Component LD50s and LC50s
Diphenhydramine Oral LD50 Rat = 500 mg/kg
hydrochloride Oral LD50 Mouse = 164 mg/kg
147-24-0 Intravenous LD50 Rat = 35 mg/kg
Intravenous LD50 Mouse = 20 mg/kg
Intravenous LD50 Dog = 24 mg/kg
Intravenous LD50 Rabbit = 10 mg/kg
Benzethonium chloride Oral LD50 Mouse = 338 mg/kg
121-54-0 Oral LD50 Rat = 368 mg/kg
Water Oral LD50 Rat: >50000 mg/kg
7732-18-5
Acute toxicity: Gastrointestinal effects (may include nausea/vomiting, abdominal pain, diarrhea,
dry mouth, colic). Nervous system effects (may include drowsiness, confusion,
hallucinations, convulsions, visual disturbances, headache, coma). See patient
package insert for additional information.
Chronic toxicity: Target Organs: Nervous System.
Carcinogenic effects: No data is available on the product itself.
Mutagenic effects: No data is available on the product itself.
Reproductive toxicity: No impairment to fertility based on animal data. Not considered fetotoxic based on
animal data.
FDA Pregnancy Catagory B
12. ECOLOGICAL INFORMATION
Environmental properties:
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
Component Ecotoxicity - Water Fish Species Ecotoxicity - Microtox Etoxicity
Flea Data Ecotoxicity Freshwater Algae Data
Data
Diphenhydramine hydrochloride None. None. None. None.
147-24-0
Benzethonium chloride None. None. None. None.
121-54-0
Water None. None. None. None.
7732-18-5
Ecotoxicity effects: No data available
Bioaccumulation: No data available
13. DISPOSAL CONSIDERATIONS
Waste Classification: Not regulated.
Waste from residues / unused Waste disposal must be in accordance with appropriate Federal, State, and local
products: regulations.
14. TRANSPORT INFORMATION
DOT:
DOT shipping name: None
UN Number: None
DOT Packing Group: None
DOT Hazard class: None
TDG (Canada):
TDG Proper shipping name: None
TDG UN/NA Number: None
TDG Packing Group: None
TDG Hazard class: None
ADR/RID:
ADR Official Transport Name: None
ADR Proper shipping name: None
ADR UN/NA number: None
ADR Hazard Class: None
ICAO / IATA:
IATA Proper shipping name: None
IATA UN NUMBER None
IATA Primary Hazard None
IATA Packing group: None
ICAO ERG Code: None
IMO / IMDG:
IMDG Proper Shipping Name: None
IMDG Hazard Class and Division: None
IMDG Packing Group: None
IMDG Subsidiary Risks: None
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
15. REGULATORY INFORMATION
U.S. Regulations:
TSCA Inventory List - The product is exempt from TSCA, it is FDA Regulated
OTHER REGULATIONS:
Japanese Inventory (ENCS) This product complies with JPENCS
Component Weight % RCRA Status: CERCLA CERCLA/SARA - Listed as Sara
Reportable 302 Ext. haz. 313 title III:
Quantity: substances:
Diphenhydramine hydrochloride 5 Not Listed Not Listed Not Listed Not Listed
Benzethonium chloride <0.05 Not Listed Not Listed Not Listed Not Listed
Water >94 Not Listed Not Listed Not Listed Not Listed
STATE REGULATIONS:
Component California Prop Minnesota Florida Right- Rhode Island Massachusetts Pennsylvania New Jersey Right-to-
65: Right-To - to-Know Right-to-Know Right-to-Know Right-to-Know: Know:
Know: Reporting List: List: List:
Diphenhydramine hydrochloride Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed
Benzethonium chloride Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed
Water Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed
CANADIAN REGULATIONS:
Canada DSL Inventory List - This product does not comply with DSL
EU EINECS List - This product complies with EINECS
Risk Phrases:
NONE
Safety Phrases:
NONE
16. OTHER INFORMATION
This data sheet contains changes from the previous version in section(s)?:
Additional product codes.
Additional information:
Not Available.
Prepared by: Technology Resources, Baxter Healthcare Corporation
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier 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.
End of safety data sheet:
______________________________________________________________
Product id: 1102387 Product name: Diphenhydramine Hydrochloride
Injection, USP
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