MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. 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: Zinc Oxide Ointment USP
Synonyms: Not applicable.
CAS #: Not applicable.
Chemical Family: M etal oxide in saturated hydrocarbon (alkane).
Formula: Zinc Oxide USP, M ineral Oil USP, W hite Petrolatum USP, W hite W ax NF (Beeswax).
SECTION 2: SAFETY and HAZARD RATINGS
RATINGS
Health (Acute-Chronic): 1鈥?0
Minimal 0
Flammability: 1
Slight 1
Reactivity: 0
Moderate 2
Environment (Air-W ater-Soil): 0鈥?2鈥?1
Severe 3
Special Hazards: None indicated.
Extreme 4
Protective Equipment: General ventilation, eye and hand wash. Use apron, gloves and safety
glasses (not during standard application).
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: If swallowed, get medical help or contact a Poison Control Center right away. 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
Zinc Oxide 1314-13-2 no no no not established
0.2mg/m3 * 5.0mg/m3*
Mineral Oil 8042-47-5 no no no
White Petrolatum 8009-03-8 no no no not established
White Wax (Beeswax) 8006-40-4 no no no not established
*as mist
M SDS# 06A Zinc Oxide Ointment USP (M arch 31, 2006) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature NF: Not indicated.
Flammable Limits in Air by Volume LEL: Not indicated.
UEL: Not indicated.
Extinguishing M edia: Alcohol foam, Dry chemical, W ater fog.
Special Fire Fighting Procedures: W ear protective clothing and self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: Zinc oxide fume.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid oxidants and extreme heat.
Hazardous Combustion or Zinc oxide fumes and 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 irritation of the eyes and skin.
b. Chronic Effects: b. Not indicated.
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. M ay cause irritation. Not for ophthalmic use.
3. Skin: 3. No effects expected under normal conditions of use.
4. Ingestion: 4. M ay produces a laxative effect.
5. M edical Conditions 5. Not indicated.
Potentially Aggravated:
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Avoid oxidants and extreme heat. Store at
Handling/Storage: room temperature, do not exceed 30NC (86NF).
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 Zinc Oxide 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. Avoid oxidants and extreme heat.
Store at room temperature, do not exceed 30NC (86NF).
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 W ith: Adequate, general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: For external use only. Avoid contact with eyes.
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 aw ay from strong oxidants and extreme heat.
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: FDA: 21 CFR 330.5
NDC: 0168-0062-02
0168-0062-16
0168-0062-31
M SDS# 06A Zinc Oxide Ointment USP (M arch 31, 2006) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white ointment with a faint odor.
M olecular W eight: Not applicable.
pH: Not indicated.
Refractive Index @ 20NC: Not indicated.
Viscosity CPS @ 25NC: Not indicated.
>121 OF (>250 OC)
Boiling Point:
Freezing/M elting Point: Not indicated.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): <1
Vapor Density (Air=1): 0
Solubility in W ater: Insoluble.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Specific Gravity (H 2O=1): 1.01 @ 20NC
% Volatile by Volume: Not indicated.
Evaporation Rate (Ether=1): 0.00
Date of Preparation/Change: Revision # 3 Replaces
March 31, 2006 March 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 Zinc Oxide Ointment USP (M arch 31, 2006) Page 4 of 4
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