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 Oral Suspension USP
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Pharmaceutical Antifungal Antibiotic.
Formula: Ethanol, Sucrose, Nystatin USP M icronized, Glycerin USP, M int Blend Flavoring, Dibasic Sodium
Phosphate USP, Silicon Dioxide NF, M ethylparaben NF, Propylparaben NF, and Purified W ater USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 0鈥?1 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: 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. 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
Ethanol 64-17-5 1000ppm 1000ppm
no no no
<1.0
50.0 10mg/m3 15mg/m3 **
Sucrose 57-50-1 no no no
Nystatin 1400-61-9 not established
no no no
10mg/m3 * 15mg/m3 **
Glycerin 56-81-5
no no no
Mint Blend Flavoring n/a not established
no no no
Dibasic Sodium Phosphate 7558-79-4 not established
no no no 10mg/m3
Silicon Dioxide 7631-86-9 20mpcf
no no no
Methylparaben 99-76-3 not established
0.12
no no no
0.03
Propylparaben 94-13-3 not established
no no no
Water 7732-18-5 not established
*mist ** total dust
M SDS# 05A Nystatin Oral Suspension USP (April 4, 2005)
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SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature oF: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide, W ater spray.
Special Fire Fighting Procedures: Use self-contained breathing apparatus and protective clothing.
Unusual Fire and Explosion Hazards: Exposure to strong oxidizers (such as chlorates and permanganates) may cause
an explosion.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Strong oxidizers, extremes of phH, sources of heat, light and flame, and
freezing.
Hazardous Combustion or Decomposition Products: M ay emit toxic fumes in a fire.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause diarrhea, nausea and vomiting.
b. Chronic Effects b. M ay cause diarrhea, nausea, vomiting and skin rash. M ay cause allergic reaction in
susceptible individuals.
1. Inhalation: 1. M ay cause irritation.
2. Eyes: 2. M ay cause irritation.
3. Skin: 3. M ay cause local irritation, stinging or burning.
4. Ingestion: 4. None expected under normal conditions of use.
5. M edical Conditions 5. Allergic reaction 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 strong oxidizers,
Handling/Storage: extremes of pH, sources of heat, light and flame. Store at controlled room
temperature 20 o鈥?25 oC (68 o鈥?77 oF) with excursions permitted at 15 o鈥?30 oC (59 o鈥?86 oF).
Avoid 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: Avoid any ignition sources. Use non-sparking tools. Absorb on sand or vermiculite
and place in closed containers for disposal. Ventilate and wash area after material
pickup is complete, Report major leaks and spills to the appropriate local, state
and/or federal governmental agency.
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 Nystatin Oral Suspension USP (April 4, 2005)
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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. Do not handle or store near flame,
heat, light, oxidants and bases. Store at controlled room temperature
20 o鈥?25 oC (68 o鈥?77 oF) with excursions permitted at 15 o鈥?30 oC (59 o鈥?86 oF).
Avoid freezing.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, flame, heat, light, oxidants and bases.
Container Should be Handled in an Area with: Cool, dry conditions. Avoid freezing.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription.
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 flame, heat, light, oxidants and bases. Excursions permitted
at 15 o鈥?30 oC (59 o鈥?86 oF).
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: 0168-0037-60
0168-0037-74
M SDS# 05A Nystatin Oral Suspension USP (April 4, 2005)
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SECTION 13: PHYSICAL DATA
Appearance and Odor: A light yellow liquid suspension with an odor of mint.
M olecular W eight: Not applicable.
pH: 6.0鈥?7.5
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: Not determined.
~100 oC (212 oF)
Boiling Point:
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M ostly miscible.
Solubility in Alcohol: M ostly miscible.
Solubility in Oil: Insoluble.
Solubility in Other: Not determined.
1.23 @ 25 oC (77 oF)
Specific Gravity (H 2O=1):
% Volatile by Volume: Not determined.
Evaporation Rate (Ether=1): 0.03
Date of Preparation/Change: Revision # 3 Replaces
April 4, 2005 October 25, 2004
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 Nystatin Oral Suspension USP (April 4, 2005)
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