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 and Triamcinolone Acetonide Ointment USP
Synonyms: M ystrex Ointment
CAS #: Not applicable.
Chemical Family: Pharmaceutical ointment.
Formula: Polyoxyethylene Fatty Alcohol Ether, W hite Petrolatum USP, Glyceryl M onostearate Non-NF,
Polyethylene Glycol 400 M onostearate, Sorbitol Solution USP, Simethicone Emulsion USP, Benzyl
Alcohol NF, Propylene Glycol USP, Rehydragel鈩? Aluminum Hydroxide Gel, Aluminum Hydroxide Gel
F500, Polysorbate 60 NF, Titanium Dioxide NF, Triamcinolone Acetonide USP (M icronized), Nystatin
USP M icronized, AC Polyethylene 3A (Polyethylene), M ineral Oil USP.
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): 0-2-1 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 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
M SDS# 06A Nystatin and Triamcinolone Acetonide Ointment USP (M arch 31, 2006) Page 1 of 5
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
Polyoxyethylene Fatty Alcohol Ether n/a no no no not established
White Petrolatum 8009-03-8 no no no not established
Glyceryl Monostearate 123-94-4 no no no not established
Polyethylene Glycol 400 Monostearate 9004-99-3 no no no not established
Sorbitol 50-70-4 no no no not established
Simethicone 8050-81-5 no no no not established
Benzyl Alcohol 100-51-6 no no no not established
Propylene Glycol 57-55-6 no no no not established
Aluminum Hydroxide 21645-51-2 no no no not established
Polysorbate 60 9005-67-8 no no no not established
Titanium Dioxide 13463-67-7 no no no not established
Triamcinolone Acetonide 76-25-5 no no no not established
Nystatin 1400-61-9 no no no not established
A.C. Polyethylene 3A (Polyethylene) 9002-88-4 no no no not established
0.2mg/m3* 5.0mg/m3*
Mineral Oil 8012-95-1 no no no
*as mist
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 in a fire.
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
M SDS# 06A Nystatin and Triamcinolone Acetonide Ointment USP (M arch 31, 2006) Page 2 of 5
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis,
manifestations of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. M ay cause
allergic reaction and skin irritation in sensitive individuals.
b. Chronic Effects: b. Systemic absorption may cause effects similar to overexposure. Carcinogenicity
studies on 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.
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 hyperglycemia and glycosuria.
5. M edical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and
Potentially Aggravated: allergy in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container tightly closed at all times when not in use. Store at controlled room
Handling/Storage: temperature 15鈥?30NC (59鈥?86NF). Avoid freezing. 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.
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.
M SDS# 06A Nystatin and Triamcinolone Acetonide Ointment USP (M arch 31, 2006) Page 3 of 5
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container tightly closed at all times when not in use. Store at controlled
room temperature 15鈥?30NC (59鈥?86NF). Avoid freezing. Avoid extreme heat,
sparks, open flame, and oxidizers.
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage 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 a prescription. For dermatologic
use only. Not for ophthalmic use. Pregnant and nursing women should avoid
this treatment if possible.
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: No 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: 0168-0089-15
0168-0089-30
0168-0089-60
M SDS# 06A Nystatin and Triamcinolone Acetonide Ointment USP (M arch 31, 2006) Page 4 of 5
SECTION 13: PHYSICAL DATA
Appearance and Odor: A yellow ointment that is essentially odorless.
M olecular W eight: Not applicable.
pH: Not applicable.
Refractive Index @ 20NC: Not applicable.
Viscosity @ 25NC: Not determined.
Boiling Point: ~157NC (~315NF)
Freezing/M elting Point: ~86NC (~187NF)
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: M ostly insoluble.
Solubility in Alcohol: Partly soluble.
Solubility in Oil: M ostly soluble.
Solubility in Other: Not determined.
Specific Gravity (H 2O=1): 0.86 @ 20NC
% 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
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