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: Nitroglycerin Ointment USP, 2%
Synonyms: Nitrol Ointment 2%
CAS #: 55-63-0
Chemical Family: N/A
Formula: Nitroglycerin in a Lactose Diluent, W hite Petrolatum, Lanolin USP, and Purified W ater.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 2-2 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-0-0 M oderate 2
Special Hazards: None. Severe 3
Protective Equipment: Applicator pads for normal use. Gloves and goggles for large quantities. Extreme 4
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush immediately with plenty of water for at least 15 minutes. Get medical attention.
Skin: W ash immediately and thoroughly with soap and water. If redness, itching or burning sensation develops, or
person feels sick or dizzy, get medical attention. W ash contaminated clothing before reuse.
Ingestion: Contact physician immediately.
Inhalation: No applicable with normal use. In cases of overexposure, remove to fresh air. If breathing is difficult, give
oxygen. If breathing has stopped, give artificial respiration. Contact a physician.
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
Nitroglycerin 55-63-0 no no no 0.5ppm .2ppm
2
Lanolin (hydrous) 8020-84-6 no no no not established
Purified Water 7732-18-5 no no no not established
White Petrolatum 8009-03-8 no no no not established
M SDS# 04A Nitroglycerin Ointment USP 2% (M ay 27, 2004) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
>110 0C (230 0F) (Closed Cup)
Flash Point:
Auto-ignition Temperature 0F: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: W ater, Carbon Dioxide, M onoammonium Phosphate Dry Pow der, Halon 12M .
Special Fire Fighting Procedures: Self-contained breathing apparatus, barricade.
Unusual Fire and Explosion Hazards: This product will burn, but is not explosive and will not detonate. Nitroglycerin
is a powerful explosive and separation of it from the ointment is extremely
hazardous. If the fire is intense, product will be entirely consumed. Less intense
smoldering-type fires can cause nitroglycerin to migrate and collect, leading to
an explosion if sufficient heat is present.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Avoid high temperature in storage, contact with water, acid, base, and oxidizing materials.
Chemicals to Avoid:
Hazardous Combustion or Nitrogen oxides.
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 nausea, dizziness, vomiting, headache, reduced blood pressure, cyanosis.
b. Chronic Effects: b. M ay cause severe headache, hallucinations, skin rash.
1. Inhalation: 1. None expected under normal conditions of use. Excessive exposure may result in
overexposure effects.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause irritation.
4. Ingestion: 4. M ay cause nausea, vomiting, dizziness, headache, reduced blood pressure, cyanosis.
5. M edical Conditions 5. Hypotension.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Product should be stored in cool, dry place, away from sources of heat and flammable
Handling/Storage: materials. Facility should be equipped with adequate fire protection. Store at controlled
room temperature 59 0-86 0F (15 0-30 0C). Avoid high temperatures.
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 unless
thoroughly laundered.
W hen M aterial is DO NOT FLUSH W ITH W ATER. Assure slippery conditions are nullified. Add sand or
Released or Spilled: dirt. Scoop up and remove to plastic-lined fiber containers immediately. 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 Nitroglycerin Ointment USP 2% (M ay 27, 2004) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: General ventilation.
Skin Protection: Applicator pads with normal use. Latex or rubber gloves for large quantities. do
not wear plastic gloves unless cotton gloves are worn underneath.
Eye Protection: Safety glasses with side shields, or safety goggles.
Other Protective Clothing or Equipment: None with normal use. As needed to prevent repeated/prolonged contact.
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Store in cool, dry conditions
(temperature controlled: 59 0-86F, 15-30 0C) and away from sources of
water, acids, bases and oxidizing materials. Facility should be equipped
with adequate fire protection system.
Recommended Container: As supplied.
Protect the Container by: Avoiding physical damage and heat.
Container Should be Handled in an Area with: Temperature control, fire protection system.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. Keep tightly
closed. For topical 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 sources of heat, water, acids, bases and oxidizing
materials.
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not determined.
Biodegradability: Not determined.
Partition Coefficient: Not determined.
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:
NDC: 0168-0328-08
0168-0328-30
0168-0328-60
M SDS# 04A Nitroglycerin Ointment USP 2% (M ay 27, 2004) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: Ointment.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20 OC: Not determined.
Viscosity @ 25 OC: Not determined.
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not indicated.
Vapor Pressure (mm Hg @ 20 OC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Not determined. Do not attempt to dissolve.
Solubility in Alcohol: Not determined. Do not attempt to dissolve.
Solubility in Oil: Not determined. Do not attempt to dissolve.
Solubility in Other: No determined.
Specific Gravity (H 2O=1): 0.90
% Volatile by Volume: Not determined.
Evaporation Rate (Ether=1): 0.005
Date of Preparation/Change: Revision # 2 Replaces
M ay 27, 2004 November 26, 1996
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 Nitroglycerin Ointment USP 2% (M ay 27, 2004) Page 4 of 4
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