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: Nystatin Ointment USP
Synonyms: Nystex
CAS #: Not applicable.
Chemical Family: Antifungal antibiotic.
Formula: Nystatin USP, Polyethylene, M ineral oil.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 1 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0-0-1 M oderate 2
Special Hazards: Not indicated. 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
Nystatin 1400-61-9 no no no not established
Polyethylene 9002-88-4 no no no not established
2.0mg/m3 * 5.0mg/m3*
Mineral Oil 8012-95-1 no no no
*as mist
M SDS# 06A Nystatin Ointment USP (M arch 31, 2006) 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: W ear full protective clothing and 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 extreme heat, sparks, open flame and oxidizers.
Hazardous Combustion or Carbon dioxide, Carbon monoxide.
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, vomiting and diarrhea.
b. Chronic Effects: b.
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. Not for ophthalmic use鈥搈ay cause irritation.
3. Skin: 3. Non-toxic under standard application. If irritation should occur, discontinue use.
4. Ingestion: 4 M ay cause nausea, vomiting, diarrhea and stomach pain.
5. M edical Conditions 5. M ay cause allergic reactions is susceptible individuals. Carcinogenicity studies on
Potentially Aggravated: polyethylene (19,157,79) and highly refined mineral oils (IARC M onographs,
Suppl. 7,252,1987) have been reviewed by IARC who found that they do not
permit an evaluation of its carcinogenicity.
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
Handling/Storage: 15鈥?30NC (59鈥?86NF). Avoid extreme heat, sparks, open flame, and oxidizers.
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# 06A Nystatin Ointment USP (M arch 31, 2006) 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. Store at controlled room temperature
15鈥?30NC (59鈥?86NF). Avoid extreme heat, sparks, open flame, and oxidizers.
As supplied (not sold in bulk quantity).
Recommended Container: Avoid physical damage and heat.
Protect the Container by: Cool, dry conditions.
Container Should be Handled in an Area with: Not reusable.
The Empty Container is: Federal law prohibits dispensing without a prescription. For topical use only.
Precautionary Label: Keep out of reach of children.
W arning Placard: Not applicable.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable
Shipping Instructions: Keep away from extreme heat, sparks, open flame, and oxidizers.
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 references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0007-15
0168-0007-30
M SDS# 06A Nystatin Ointment USP (M arch 31, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A yellow-to-tan ointment that is essentially odorless.
M olecular W eight: Not applicable.
pH: Not determined.
Refractive Index @ 20NC: Not applicable.
Viscosity @ 25NC: Not determined.
Boiling Point: 155NC (311NF)
Freezing/M elting Point: Not determined.
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: Partly soluble.
Solubility in Oil: M ostly soluble.
Specific Gravity (H 2O=1): 0.83 @ 50NC
% Volatile by Volume: 0
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 2 Replaces
M arch 31, 2006 M arch 31, 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. 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# 06A Nystatin Ointment USP (M arch 31, 2006) Page 4 of 4
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