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 Cream USP, 0.5%, 1% and 2.5%
Synonyms: None.
CAS #: None.
Chemical Family: Adrenocortical Cream
Formula: Hydrocortisone, Glycerin, Potassium Sorbate, Benzyl Alcohol, Lactic Acid 88%, Purified Water, Paraffin, Stearyl
Alcohol, Glyceryl Monostearate, Isopropyl Palmitate, Polyoxyl 40 Stearate, and Sorbitan Monostearate.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-0 Moderate 2
Special Hazards: Not indicated. Severe 3
Protective Equipment: General ventilation, eye and hand wash. (Not under standard application.) 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 if directed by medical personnel. 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
C A R C IN O G E N H A ZA R D D A T A
A C G IH O SH A
NAM E C A S# % IA R C NTP O SH A TLV PEL
Hydrocortisone 50-23-7 no no no not established
Glycerin 56-81-5 no no no not established
Potassium Sorbate 590-00-1 no no no not established
Benzyl Alcohol 100-51-6 no no no not established
Lactic Acid 50-21-5 no no no not established
Purified Water 7732-18-5 no no no not established
Paraffin 64742-43-4 no no no not established
Stearyl Alcohol 112-92-5 no no no not established
Glyceryl Monostearate 123-94-4 no no no not established
Isopropyl Palmitate 142-91-6 no no no not established
Polyoxyl 40 Stearate 9004-99-3 no no no not established
Sorbitan Monostearate 1338-41-6 no no no not established
M SDS# 05A Hydrocortisone Cream USP, 0.5% , 1% and 2.5% (M arch 15, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature oF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing Media: Foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus when firefighting.
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 oxidants, strong acids, alkalies and extreme heat.
Hazardous Combustion or Decomposition Carbon dioxide, Carbon monoxide.
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 reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis, manifestations of
b. Chronic Effects: Cushing鈥檚 syndrome, hyperglycemia and glucosuria. May cause allergic reaction and skin irritation
in sensitive individuals.
1. Inhalation: None expected under normal condition of use.
2. Eyes: Topical forms will cause moderate irritation. Not for ophthalmic use.
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
Keep container closed when not in use. Store at controlled room temperature 15o-30oC
Precautions to be Taken in
(59o-86oF). Avoid strong oxidants, strong acids, alkalies and extreme heat.
Handling/Storage:
Hygienic Practices: Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
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.
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.
M SDS# 05A Hydrocortisone Cream USP, 0.5% , 1% and 2.5% (M arch 15, 2005) Page 2 of 4
SECTION 10: CONTAINERS and LABELING
Keep container closed when not in use. Store at controlled room temperature 15o-30oC
Special Precautions:
(59o -86o F). Avoid strong oxidants, strong acids, alkalies and extreme heat.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and heat.
Container Should be Handled in an Area With: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For external use only. Not for
ophthalmic use. (See package insert.)
Warning Placard: Keep out of reach of children. Not to be used on children under 2 years of age.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from oxidizers, strong acids, alkalies, 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 references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: FDA: 21 CFR 330.5
NDC: 0.5% (OTC) 0168-0014-31
1% (OTC) 0168-0154-08, 0168-0154-31
1% (Rx) 0168-0015-31, 0168-0015-16
2.5% (Rx) 0168-0080-31, 0168-0080-16
Federal law prohibits dispensing hydrocortisone in strengths above 1% without
prescription.
M SDS# 05A Hydrocortisone Cream USP, 0.5% , 1% and 2.5% (M arch 15, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white cream with slight fatty odor.
Molecular Weight: Not applicable.
pH: Not indicated.
Refractive Index @ 20O C: Not determined.
Viscosity: Not determined.
135oC (275oF)
Boiling Point:
60oC (140oF)
Freezing/Melting Point:
Congealing Point: Not indicated.
Vapor Pressure (mm Hg @ 20O C): Not indicated.
Vapor Density (Air=1): Not indicated.
Solubility in Water: Miscible.
Specific Gravity @ 50O C: Not indicated.
% Volatile by Volume: ~ 63
Evaporation Rate (Ether=1): 0.07
Date of Preparation/Change: Revision # 3 Replaces
March 15, 2005 October 16, 2000
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. W e 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 M aterial Safety Data Sheet was prepared for ALTANA INC. by:
COM PLIANCE INNOVATIONS, INC.
706 Route 15 South, Suite 207
Lake Hopatcong, New Jersey 07849
973-663-1120 鈥? fax 973-663-2378
helpdesk@chemply.com
M SDS# 05A Hydrocortisone Cream USP, 0.5% , 1% and 2.5% (M arch 15, 2005) Page 4 of 4
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