MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & COM PANY DIVISION
PHARM ADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Hydrocortisone Lotion USP, 1% and 2.5%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical steroid lotion.
Formula: Hydrocortisone, Propylene Glycol, Sorbic Acid, Carbomer 940, Polysorbate 40, Triethanolamine,
Isopropyl M yristate, Cetyl Alcohol, Cholesterol and related sterols, Sorbitan Palmitate, Simethicone,
Propylene Glycol Stearate and W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?3 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 1鈥?1鈥?1 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: W ash 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
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 1.0, 2.5 no no no not established
Propylene Glycol 57-55-6 no no no not established
Sorbic Acid 110-44-1 no no no not established
Carbomer 940 9003-01-4 no no no not established
Polysorbate 40 9005-66-7 no no no not established
5mg/m3 not established
Triethanolamine 102-71-6 no no no
Isopropyl Myristate 110-27-0 no no no not established
Cetyl Alcohol 36653-82-4 no no no not established
Cholesterol and related sterols 57-88-5 no no no not established
Sorbitan Palmitate 26266-57-9 no no no not established
Simethicone 8050-81-5 no no no not established
10mg/m3 * not established
Propylene Glycol Stearate 1323-39-3 no no no
Water 7732-18-5 no no no not established
*as stearates
M SDS# 05A Hydrocortisone Lotion USP, 1% and 2.5% (April 5, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature oF: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus when firefighting.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid heat, light, oxidants and bases.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. May cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis, manifestations
of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. May cause allergic reaction and skin
b. Chronic Effects
irritation in sensitive individuals.
1. Inhalation:
b. Systemic absorption may cause effects similar to overexposure.
2. Eyes:
1. M ay cause irritation to throat.
3. Skin:
2. M ay cause irritation. Avoid contact with eyes.
4. Ingestion:
3. M ay cause irritation on prolonged contact. Systemic absorption may cause effects
5. M edical Conditions
similar to overexposure.
Potentially Aggravated:
4. M ay cause hyperglycemia and glycosuria.
5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy
in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not handle or store near heat, light,
Handling/Storage: oxidants and bases.
Hygienic Practices: W ash 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.
Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash area
W hen M aterial is Released or Spilled:
with soap and water. Dispose of in accordance with federal, state and local regulations.
W aste Disposal M ethods: Assure conformity with applicable disposal regulations. Dispose of absorbed material
at approved incineration or chemical landfill waste disposal site.
M SDS# 05A Hydrocortisone Lotion USP, 1% and 2.5% (April 5, 2005) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORM ATION
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 handle or store near heat,
light, oxidants or bases.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, heat and light.
Container Should be Handled in an Area with: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without prescription. For external use only.
Avoid contact with eyes. (See package insert.)
W arning Placard: Keep out of reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from heat, light, oxidants and bases.
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORM ATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: (1% ) 0168-0369-04, 0168-0287-04
(2.5% ) 0168-0288-02
M SDS# 05A Hydrocortisone Lotion USP, 1% and 2.5% (April 5, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance (and Odor): A translucent, white to off-white, smooth and homogeneous lotion.
M olecular W eight: Not applicable.
pH: 4.0鈥?6.5
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 5,000鈥?35,000 cps
~107 oC (~224.6 oF)
Boiling Point:
36 oC (96.8 oF)
Freezing/M elting Point:
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Insoluble.
Solubility in Alcohol: Soluble.
Solubility in Oil: Insoluble.
Solubility in Other: Not determined.
1.27 @ 25 oC (77 oF)
Specific Gravity (H 2O=1):
% Volatile by Volume: ~ 82% (v/v) water
Evaporation Rate (Ether=1): 0.1
Date of Preparation/Change: Revision # 1 Replaces
April 5, 2005 June 10, 1999
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 Lotion USP, 1% and 2.5% (April 5, 2005) Page 4 of 4
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