MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. Fougera & Co.
Pharmaderm
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
Emergency Telephone No.: 631-454-7677
800-424-9300
SECTION 1: IDENTITY
Product Name: Hydrocortisone Ointment USP, 2.5%
Synonyms: None indicated.
CAS #: None.
Chemical Family: Topical corticosteroid.
Formula: Hydrocortisone USP micronized, Mineral oil USP and White petrolatum USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?2 RATINGS
Flammability: 1 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0鈥?1鈥?3 Moderate 2
Special Hazards: Not 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 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 2.5 no no no not established
White petrolatum 8009-03-8 no no no not established
.2mg/m3* 5mg/m3*
Mineral oil 8042-47-5 no no no
* m ist
M SDS# 06A Hydrocortisone Ointment USP, 2.5% (December 15, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature 潞F: 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 when firefighting.
Unusual Fire and Explosion Hazards: May emit toxic fumes when burning.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong oxidizers or acids.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
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: 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
irritation in sensitive individuals.
b. Chronic Effects: b. Systemic absorption may cause effects similar to overexposure.
1. Inhalation: 1. None expected under normal condition of use.
2. Eyes: 2. May cause irritation. Not for ophthalmic use.
3. Skin: 3. May cause irritation. For topical use only.
4. Ingestion: 4. May result in absorption of corticosteroid. May induce low toxicity.
5. Medical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction. Sensitivity to corticosteroids or any
Potentially Aggravated: ingredient in this preparation.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Store at controlled room temperature 15潞鈥?30潞C
Handling/Storage: (59潞鈥?86潞F). Do not store or mix with strong oxidizers or acids. Keep away from heat and flame.
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# 06A Hydrocortisone Ointment USP, 2.5% (December 15, 2006) Page 2 of 4
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Store at controlled room temperature 15潞鈥?30潞C
(59潞鈥?86潞F). Do not store or mix with strong oxidizers or acids. Keep away 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 an Area With: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For dermatologic use only. Not
for ophthalmic use. (See package insert).
Warning Placard: Keep out of reach of children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not 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 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: 0168-0146-30
0168-0146-16
M SDS# 06A Hydrocortisone Ointment USP, 2.5% (December 15, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance: A white ointment with a slightly fatty odor.
Molecular Weight: Not indicated.
pH: Not indicated.
Refractive Index @ 20潞C: Not indicated.
Viscosity @ 25潞C: Not indicated.
Boiling Point: 135潞C (275潞F)
Freezing/Melting Point: 60潞C (140潞F)
Congealing Point: Not indicated.
Vapor Pressure (mm Hg @ 20o C): 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 (H2 O=1): Not indicated.
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 3 Replaces
December 15, 2006 November 17, 2003
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
M SDS# 06A Hydrocortisone Ointment USP, 2.5% (December 15, 2006) Page 4 of 4
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