Emergency Assistance:
CHEMTREC庐 (24-hour)
1-800-424-9300
3940 Quebec Avenue North
Paddock Technical Assistance:
Minneapolis, MN 55427
1-800-328-5113
Tel: (763) 546-4676
MATERIAL SAFETY DATA SHEET
Hydrocortisone Acetate Suppositories, 25 mg & 30 mg
Creation Date: 07-10-2003 Revision Date: 04-24-2006
SECTION 1: PRODUCT IDENTIFICATION
Hydrocortisone Acetate Suppositories, 25 mg & 30 mg
Product Name
Hydrocortisone Acetate
Common Name/Trade Name
Paddock Laboratories, Inc.
Manufacturer
Cortisol Acetate Suppositories
Synonyms
Hydrocortisone Acetate
Chemical Name
Steroid/Anti-Inflammatory
Chemical Family
C23H32O6
Chemical Formula
SECTION 2: COMPOSITION AND INGREDIENTS
CHEMICAL NAME CAS# % OSHA PEL ACGIH TLV IDLH
50-03-3 <2 NA NA NA
Hydrocortisone Acetate
NA 98.6 NA NA NA
Hydrogenated Vegetable Oil
Paddock Laboratories, Inc. Page 1 of 6
SECTION 3: HAZARDS IDENTIFICATION
Hazardous in case of skin contact (irritant,
permeator), of eye contact (irritant), of ingestion, of
Potential Acute and Chronic Health Effects
inhalation.
NA
Pregnancy Comments
SECTION 4: FIRST AID MEASURES
Thoroughly wash with mild soap and water. If
Skin Exposure
irritation persists or develops, seek medical attention.
Immediately flush with water for 15 minutes. If
Eye Exposure
irritation persists or develops, seek medical attention.
No adverse effects expected.
Inhalation
Flush out mouth with water. Seek medical attention
Ingestion
immediately. Do not induce vomiting.
SECTION 5: FIRE / EXPLOSION HAZARDS & FIREFIGHTING MEASURES
Maybe combustible at high temperatures.
Flammability of the Product
NA
Auto-ignition Temperature
NA
Flash Points
Lower: NA Upper: NA
Flammable Limits (in air by volume, %)
Use extinguishing agent suitable for type of
surrounding fire.
Fire Extinguishing Equipment Water Spray: OK
Foam: OK
Carbon Dioxide: OK
Dry Chemical: OK
Other: Any 鈥淎BC鈥? class
This material may produce toxic carbon monoxide
Unusual Fire and Explosion Hazards
and carbon dioxide fumes if heated to decomposition.
Explosion Hazards in presence of Various
NA
substances
Firefighters should wear full protective gear
Firefighting Procedures
including self contained breathing apparatus.
Paddock Laboratories, Inc. Page 2 of 6
SECTION 6: SPILL AND LEAK PROCEDURES
Use appropriate tools to put the spilled solid in a
convenient waste disposal container. Finish cleaning
Spills by spreading water on the contaminated surface and
dispose or according to local and regional authority
requirements.
SECTION 7: HANDLING AND STORAGE
As with all chemicals, avoid getting this product ON
YOU or IN YOU. Do not eat, drink or smoke or
Work and Hygiene Practices
apply cosmetics while handling the product. Wash
hands thoroughly after handling.
Store at controlled room temperatures below 30掳C
(86掳F). Keep away from sources of ignition. Wash
Storage and Handling Practices
hands before eating. Avoid contact with eyes, skin
and clothing.
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
Under normal conditions of use, no special controls
Engineering Controls
are required.
Personal Protection
No special requirements.
Respiratory Protection
Safety glasses or goggles.
Eye Protection
Gloves.
Hand Protection
Lab coat.
Body Protection
SECTION 9: PHYSICAL / CHEMICAL PROPERTIES
White to creamy white suppository.
Physical state and appearance
NA
Molecular Weight
NA
Boiling Point
NA
Vapor Density (AIR=1)
NA
Vapor Pressure (mm Hg)
32-35掳C
Melting/Freezing Point
Paddock Laboratories, Inc. Page 3 of 6
NA
pH
NA
Water Solubility
<1
Specific Gravity (Water =1)
No
Water Reactivity
NA
Volatility
Practically odorless.
Odor
SECTION 10: STABILITY AND REACTIVITY
This product is stable.
Stability
NA
Incompatible Temperature
NA
Incompatible Materials
NA
Conditions of Instability
NA
Hazardous Polymerization
May produce toxic carbon monoxide and carbon
Hazardous Decomposition
dioxide fumes if heated to decomposition.
None known at this time.
Conditions to Avoid
SECTION 11: TOXICOLOGICAL INFORMATION
Toxicity (information for Hydrocortisone Intraperitoneal Rat LD50: 2300 mg/Kg
Subcutaneous Mouse LD50: 45 mg/Kg
Acetate)
No
Suspected Cancer Agent
SECTION 12: ECOLOGICAL INFORMATION
NA
Environmental Stability
NA
Ecotoxicity
The products of degradation are more toxic.
Products of Biodegradation
NA
Special Remarks
SECTION 13: WASTE DISPOSAL
Dispose of material according to local, state, federal and environmental disposal regulations or company
operating procedures.
Paddock Laboratories, Inc. Page 4 of 6
SECTION 14: TRANSPORTATION INFORMATION
Not a DOT controlled material.
DOT classification
NA
Identification
NA
DOT Label(s) Required
SECTION 15: REGULATORY INFORMATION
311/312 Hazard Categories: Immediate Health, 313
US SARA Reporting Requirements
Reportable Ingredients: None.
NA
Federal and State Regulations
Hydrocortisone Acetate Suppository is a 鈥渄rug鈥? as
defined by the Federal Food, Drug and Cosmetic Act
U.S. TSCA Inventory Status
and is therefore not a chemical substance under
TSCA.
SECTION 16: OTHER INFORMATION
DEFINITIONS OF ABBREVATIONS USED:
American Conference of Governmental Industry Hygienists
ACGIH
Chemical Abstract Service
CAS
International Agency for Research on Cancer
IARC
Immediately Dangerous to Life or Health Level
IDLH
Medial Lethal Concentration
LC50
Medial Lethal Dose
LD50
Mine Safety and Health Administration
MSHA
Not Available
NA
No Data
ND
Not Established
NE
National Institute for Occupational Safety and Health
NIOSH
National Toxicology Program
NTP
Occupational Safety and Health Administration
OSHA
Permissible Exposure Limit
PEL
Superfund Amendments and Reauthorization Act
SARA
Short Term Exposure Limit
STEL
Threshold Limit Value
TLV
Time Weighted Average
TWA
SECTION 17: DISCLAIMER
The information contained in this Material Safety Data Sheet has been compiled from reliable sources and
Paddock Laboratories, Inc. Page 5 of 6
is believed to be correct as of the date issued. It is the responsibility of the user to determine the
appropriateness and applicability to their situation. Paddock Laboratories, Inc. disclaims any expressed or
implied warranty as to the accuracy of the above information and shall not be held liable for any direct,
incidental, or consequential damages from use or reliance on the above information.
Paddock Laboratories, Inc. Page 6 of 6
|