MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. 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: Gentamicin Sulfate Ophthalmic Ointment USP
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Antibiotic.
Formula: Gentamicin Sulfate, White Petrolatum and M ineral Oil.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?0 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0鈥?0鈥?1 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: None required under standard usage. 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
Gentamicin Sulfate 1405-41-0 no no no not established
White Petrolatum 8009-03-8 no no no not established
0.2mg/m3* not established
Mineral Oil 8042-47-5 no no no
* oil mist (mineral)
M SDS# 05A Gentamicin Sulfate Ophthalmic Ointment USP (October 4, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature NF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus.
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,
Signs and Symptoms of Exposure
a. Overexposure Effects: a. Possible allergic reaction.
b. Chronic Effects b. Possible hypersensitization
1. Inhalation: 1. Not likely due to physical state of the product.
2. Eyes: 2. Not toxic under normal conditions of use.
3. Skin: 3. NOT FOR INJECTION INTO THE EYE. M ay cause skin irritation.
4. Ingestion: 4. M ay cause irritation.
5. M edical Conditions 5. Hypersensitivity to any of the ingredients.
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 heat, light,
Handling/Storage: oxidants and bases. Store at 25NC (77NF); excursions permitted to 15鈥?30NC
(59鈥?86NF).
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# 05A Gentamicin Sulfate Ophthalmic Ointment USP (October 4, 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: Do not handle or store near heat, light, oxidants and bases. Store at 25NC
(77NF); excursions permitted to 15鈥?30NC (59鈥?86NF).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, flame and heat.
Container Should be Handled in an Area with: Cool, dry conditions.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without prescription. For topical
ophthalmic use only.
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: 0168-0044-38
M SDS# 05A Gentamicin Sulfate Ophthalmic Ointment USP (October 4, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white to off-white ointment with essentially no odor.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20NC: Not determined.
Viscosity @ 25NC: 10鈥?50 cSt
Boiling Point: Decomposition begins at ~185NC (365NF)
Freezing/M elting Point: M elts at ~42NC (~107.6NF)
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Insoluble.
Solubility in Alcohol: Insoluble.
Solubility in Oil: M iscible.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 0.87 @ 60NC
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0.01
Date of Preparation/Change: Revision # 2 Replaces
October 4, 2005 October 14, 2002
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 Gentamicin Sulfate Ophthalmic Ointment USP (October 4, 2005) Page 4 of 4
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