MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Hydrocortisone Ointment USP
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Adrenocortical ointment.
Formula: Hydrocortisone USP Micronized, Mineral Oil USP, White Petrolatum USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 1 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-0 Moderate 2
Special Hazards: None indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EMERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: Wash thoroughly with soap and water.
Ingestion: Give two glasses of water and induce vomiting. Never give anything by mouth to an unconscious person.
Inhalation: Remove to fresh air. If breathing is difficult, give oxygen. If breathing has stopped, give artificial respiration.
CALL A PHYSICIAN
CONTACT A POISON CONTROL CENTER
SECTION 4: INGREDIENTS
CARCINOGEN HAZARD DATA
ACGIH OSHA
NAME CAS# % IARC NTP OSHA TLV PEL
Hydrocortisone 50-23-7 no no no not established
.25mg/m3 5mg/m3
Mineral Oil 8042-47-5 no no no
White Petrolatum 8009-03-8 no no no not established
MSDS# 03A Hydrocortisone Ointment, USP (November 17, 2003) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature 0F: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing Media: Alcohol Foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: Do not store or mix with strong oxidizers or acids.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidizers or acids.
Hazardous Combustion or Carbon dioxide, Carbon monoxide.
Decomposition Products:
Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: May cause skin irritation and allergic reactions in sensitive individuals.
b. Chronic Effects: May cause skin irritation and allergic reactions in sensitive individuals.
1. Inhalation: Not likely under normal conditions of use.
2. Eyes: Not for ophthalmic use unless specified on label and product insert. Topical forms will
cause moderate irritation.
3. Skin: May result in absorption corticosteroid. No effects expected under normal conditions of
use.
4. Ingestion: May result in absorption of corticosteroid. May induce low toxicity.
5. Medical Conditions Skin conditions. Systemic effects may be produced.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not store or mix with strong oxidizers or
Handling/Storage: acids. Keep away from heat and flame.
Hygienic Practices: Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
Use general ventilation to protect your lungs. Do not wear contaminated clothing
until thoroughly laundered.
When Material is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove.
Wash area with soap and water. Dispose of in accordance with federal, state and local
regulations.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed
material at approved incineration or chemical landfill waste disposal site.
MSDS# 03A Hydrocortisone Ointment, USP (November 17, 2003) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORMATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Do not store or mix with strong
oxidizers or acids. Keep way from heat and flame.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and heat.
Container Should be Handled in Adequate, general ventilation.
an Area with:
The Empty Container is: Not reusable.
Precautionary Label: None.
Warning Placard: Not to be used on children under 2 years of age. Keep Out of Reach of
Children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: No applicable.
Shipping Instructions: Keep away from oxidizers, acids and heat.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 330.5
NDC: 0168-0181-31
Federal law prohibits dispensing Hydrocortisone in strengths above 1% without a prescription.
MSDS# 03A Hydrocortisone Ointment, USP (November 17, 2003) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white ointment with a slightly fatty odor.
Molecular Weight: Not indicated.
pH: Not indicated.
Refractive Index @ 20OC: Not indicated.
Viscosity @ 25OC: Not indicated.
275OF (135OC)
Boiling Point:
140OF (60OC)
Freezing/Melting Point:
Congealing Point: Not indicated.
Vapor Pressure (mm Hg @ 20OC): Not indicated.
Vapor Density (Air=1): Not indicated.
Solubility in Water: Not miscible.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Solubility in Other: Not indicated.
Specific Gravity (H2O=1): Not indicated.
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 2 Replaces
November 17, 2003 April 29, 1992
The information presented herein relates to the specific material described and may not be valid for this material used in
combination with any other materials or in any process. This information is, to the best of our knowledge, accurate and reliable on
the date compiled. We make no representation, warranty or guarantee as to its accuracy, reliability or completeness.
It is the reader's responsibility to ascertain whether the information supplied is suitable and complete for that person's specific
uses. This Material Safety Data Sheet was prepared for ALTANA INC. by:
COMPLIANCE INNOVATIONS, INC.
706 Route 15 South, Suite 207
Lake Hopatcong, New Jersey 07849
973-663-1120 鈥? fax 973-663-2378
helpdesk@chemply.com
MSDS# 03A Hydrocortisone Ointment, USP (November 17, 2003) Page 4 of 4
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