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: Erythromycin Ophthalmic Ointment USP, Sterile
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: Antibiotics in emollients.
Formula: Erythromycin in a base of M ineral Oil and W hite Petrolatum.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 0-1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-1-1 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, 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
Erythromycin 114-07-8 no no no not established
0.2 (I)mg/m 3 5mg/m 3*
M ineral Oil 8042-47-5 no no no
W hite Petrolatum 8009-03-8 no no no not established
(I)
inhalable
* as mist
M SDS# 04A Erythromycin Ophthalmic Ointment USP, Sterile (October 25, 2004) 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 M edia: Foam, Dry chemical, Carbon dioxide, W ater spray or Fog.
Special Fire Fighting Procedures: W ear full protective clothing and self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes in a fire.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid strong acids, alkalies, oxidizers and sources of heat.
Hazardous Combustion or Carbon oxides (CO, CO 2), and Nitrous oxides (NO, NO 2) may be produced in a fire.
Decomposition Products:
Hazardous Polymerization: [ ] M ay Occur [ X ] W ill Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause allergic reactions, transient auditory impairment and liver dysfunction
b. Chronic Effects: b. M ay cause allergic reactions, reversible impairment of the liver, stomach and hearing
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. None expected under normal conditions of use.
3. Skin: 3. None expected under normal conditions of use.
4. Ingestion: 4. M ay cause liver and gastrointestinal impairment.
5. M edical Conditions 5. M ay cause skin irritation and allergies in sensitive individuals.
Potentially Aggravated:
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 acids, alkalies,
oxidizers. Store at controlled room temperature 15 o-30 oC (59 o-86 oF). Avoid excessive
Handling/Storage:
heat. Protect from freezing.
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.
W hen M aterial is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove.
W ash area 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# 04A Erythromycin Ophthalmic Ointment USP, Sterile (October 25, 2004) 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. Avoid strong acids, alkalies, oxidizers.
Avoid excessive heat. Protect from freezing.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage and excessive heat. Protect from freezing.
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. (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: No applicable.
Shipping Instructions: Keep away from strong acids, alkalies, oxidizers. Avoid excessive heat. Protect
from freezing.
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: FDA: Not applicable.
NDC: 0168-0070-11
0168-0070-38
0168-0070-39
M SDS# 04A Erythromycin Ophthalmic Ointment USP, Sterile (October 25, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A pale white ointment with no discernible odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
>250 oC (>482 oF)
Boiling Point:
43 oC (109 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: Not determined.
Solubility in Oil: Not determined.
Solubility in Other: Not determined.
0.84 @ 20 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0
Date of Preparation/Change: Revision # 3 Replaces
October 25, 2004 M ay 6, 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. 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# 04A Erythromycin Ophthalmic Ointment USP, Sterile (October 25, 2004) Page 4 of 4
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