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MSDS Material Safety Data Sheet
CAS

1400-61-9
14807-96-6

File Name: 1400-61-9.asp

                                    MATERIAL SAFETY DATA SHEET

NYSTOP鈩?

PADDOCK LABORATORIES, INC. EMERGENCY ASSISTANCE:
3940 QUEBEC AVENUE NORTH CHEMTREC 800-424-9300
MINNEAPOLIS, MINNESOTA 55427 202-483-7616
PHONE: (763)-546-4676 PADDOCK TECH. ASST. 800-328-5113

DATE PREPARED: 8-16-96 BY: Susan Schilling

SECTION 1 - PRODUCT IDENTIFICATION AND HAZARDOUS COMPONENTS

PRODUCT: Nystop, USP (Nystatin Topical Powder)

SYNONYMS: 100,000 Units Nystatin per gram Talc

MOLECULAR FORMULA: Mixture

CHEMICAL FAMILY: Polyene antifungal antibiotic

INGREDIENT (CAS #) % OSHA PEL ACGIH TLV
Nystatin (1400-61-9) 2.4 N/A N/A
2 mg/M3
Talc (14807-96-6) 97.6 20 mppcf

SECTION 2 - PHYSICAL AND CHEMICAL CHARACTERISTICS

BOILING POINT: N/A VAPOR PRESSURE: N/A

MELTING POINT: N/A VAPOR DENSITY: N/A

SPECIFIC GRAVITY: 2.5-2.8 EVAPORATION RATE: 0
(WATER = 1) (BUTYL ACETATE = 1)

WATER SOLUBILITY: Insoluble WATER REACTIVE: No

APPEARANCE AND ODOR: Pale, yellow, dry, free flowing powder.

SECTION 3 - FIRE AND EXPLOSION DATA

FLASH POINT (METHOD): N/A AUTOIGNITION TEMPERATURE: N/A

FLAMMABLE LIMITS: LOWER: N/A UPPER: N/A
MSDS - Nystop鈩? Page 2 of 4
EXTINGUISHING MEDIA: Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire
and materials.

SPECIAL FIRE FIGHTING PROCEDURES: As with all fires, evacuate all personnel to a safe area. Firefighters
should use self-contained breathing apparatus and protective clothing.

UNUSUAL FIRE AND EXPLOSION HAZARDS: None

SECTION 4 - REACTIVITY HAZARD DATA

STABILITY: Stable ( X ) Unstable ( )

INCOMPATIBILITY (MATERIALS TO AVOID): Avoid exposure to heat and moisture.

HAZARDOUS DECOMPOSITION PRODUCTS: As with any compound containing organic material, when heated
to decomposition this material could emit toxic gases.

HAZARDOUS POLYMERIZATION: May Occur ( ) Will Not Occur ( X )

SECTION 5 - HEALTH HAZARD DATA

TOXICITY: No toxicity data established for this material.

CARCINOGEN LISTED BY: NTP Yes ( ) No ( X )
IARC Yes ( ) No ( X )
OSHA Yes ( ) No ( X )
Other Yes ( ) No ( X )

Note: Talc contains trace amounts of crystalline silica. IARC has determined silica to be a class 2A carcinogen, and
NPT has classified crystalline silica as a substance reasonably anticipated to be a carcinogen.

ROUTES OF ENTRY: Inhalation, ingestion, eye and skin contact.

HEALTH HAZARDS:

ACUTE: Eye, skin, and/or respiratory tract irritation.

CHRONIC: Repeated exposure to high amounts of talc can cause Talcosis, a pulmonary fibrosis, which may
lead to severe and permanent damage to the lung- possibly resulting in disability or death.

SIGNS AND SYMPTOMS OF OVEREXPOSURE: Possible allergic reaction to dust if inhaled, ingested, or in
contact with skin and/or eyes.

MEDICAL CONDITIONS AGGRAVATED BY OVEREXPOSURE: Hypersensitivity to the material. Persons
suffering from chronic respiratory diseases may be at increased risk.
MSDS - Nystop鈩? Page 3 of 4

EMERGENCY FIRST AID PROCEDURES: Remove from exposure and remove contaminated clothing. Persons
developing serious allergic reactions must receive immediate medical attention.

EYE CONTACT Flush eyes with plenty of water for at least 15 minutes. If irritation persists, seek
medical attention.

SKIN CONTACT Wash from skin with mild soap and water.

INHALATION Remove from the exposure area.

INGESTION If conscious, give large quantities of water to induce vomiting. Get medical attention.

SECTION 6 - CONTROL AND PROTECTIVE MEASURES

RESPIRATORY PROTECTION: Wear an NIOSH approved dust mask or respirator when exposure limits may be
exceeded.

EYE PROTECTION: Safety goggles, glasses or face shield.

SKIN PROTECTION: Rubber gloves.

VENTILATION: Local ventilation recommended.

OTHER PROTECTIVE EQUIPMENT: Appropriate laboratory apparel.

HYGIENIC WORK PRACTICES: Wash clothing before reuse. Wash thoroughly after working with this material.
Avoid wearing contact lenses when working with chemicals due to the possibility of increased severity of eye injury.

SECTION 7 - HANDLING AND STORAGE PRECAUTIONS

HANDLING PRECAUTIONS: Decomposes upon exposure to heat.

STORAGE PRECAUTIONS: Store at controlled room temperature 15-30o C (59-86掳F); avoid excessive heat (40掳C;
104掳F).

OTHER PRECAUTIONS: Avoid contact with eyes, skin or clothing. Avoid breathing the dust. Wash clothes before
reuse. Wash thoroughly after handling. Do not eat, drink or smoke near this material.



SECTION 8 - SPILL AND DISPOSAL PROCEDURES

STEPS TO BE TAKEN IN CASE OF SPILL OR DISCHARGE: Wear an approved respirator and rubber gloves.
Vacuum or sweep up spillage and place in a tight container for disposal. Avoid contact with dust. Ventilate area and
wash spill site with water. Wash clothing and protective equipment before reuse.
MSDS - Nystop鈩? Page 4 of 4

WASTE DISPOSAL METHOD: Dispose of according to all local, state, federal, and environmental regulations.



SECTION 9 - DISCLAIMER

The information contained in this Material Safety Data Sheet has been compiled from reliable sources and is believed to
be correct as of the date issued. It is the responsibility of the user to determine the appropriateness and applicability to
their situation. Paddock Laboratories, Inc. disclaims any expressed or implied warranty as to the accuracy of the above
information and shall not be held liable for any direct, incidental, or consequential damages from use or reliance on the
above information.

_________________________________________________________________________________________
DEFINITIONS OF ABBREVIATIONS USED:

ACGIH: American Conference of Governmental Industrial Hygienists
CAS: Chemical Abstract Service
IARC: Internal Agency for Research on Cancer
IDLH: Immediately Dangerous to Life or Health level
LC50: Median Lethal Concentration
LD50: Median Lethal Dose
N/A: Not available
NTP: National Toxicology Program
OSHA: Occupational Safety and Health Administration
PEL: Permissible Exposure Limit
STEL: Short Term Exposure Limit
TLV: Threshold Limit Value

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