MATERIAL SAFETY DATA SHEET
Manufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO.
PHARMADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: MELVILLE, NEW YORK 11747
800-434-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Sulfacetamide Sodium Topical Suspension USP, 10%
Synonyms: None indicated.
CAS #: None indicated.
Chemical Family: Antibacterial.
Formula: Sulfacetamide sodium USP, Purified water USP, Propylene glycol USP, Lauramide DEA and diethanolamine, PEG 400
monolaurate, Hydroxyethylcellulose NF, Sodium chloride USP, Sodium metabisulfite NF, Methylparaben NF, Xantham
gum NF, EDTA, and Simethicone emulsion USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0-1-1 Moderate 2
Special Hazards: None. Severe 3
Protective Equipment: General ventilation, eye and hand wash. Extreme 4
SECTION 3: EMERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: Wash 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. Give artificial respiration if breathing has stopped.
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
Sulfacetamide sodium monohydrate 6209-17-2 10.0 no no no not established
Water 7732-18-5 no no no not established
Propylene glycol 57-55-6 no no no not established
Lauramide DEA 120-40-1 no no no not established
2mg/m3 not established
Diethanolamine 111-42-2 no no no
PEG 400 monolaurate 61791-29-5 no no no not established
Hydroxyethylcellulose 9004-62-0 no no no not established
Sodium chloride 7647-14-5 no no no not established
5mg/m3 not established
Sodium metabisulfite 7681-57-4 no no no
Methylparaben 99-76-3 no no no not established
Xantham gum 11138-66-2 no no no not established
EDTA 60-00-4 no no no not established
Simethicone emulsion 67762-90-7 no no no not established
M SDS# 05A Sulfacetamide Sodium Topical Suspension USP, 10% (November 7, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature 潞F: 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.
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 heat, light, oxidants, and bases.
Hazardous Combustion or Carbon dioxide, carbon monoxide, phosgene and oxides of nitrogen and sulfur may
Decomposition Products: be generated in a fire.
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:
b. Chronic Effects: M ay cause allergic reaction and skin irritation.
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. M ay cause irritation.
4. Ingestion: 4. Not expected under normal conditions of usage.
5. M edical Conditions 5. Skin irritation and allergy in individuals sensitive to sulfonamides or any other
Potentially Aggravated: ingredients.
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: 20潞鈥?25潞C (68潞鈥?77潞F). Avoid heat, light, oxidants and bases.
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# 05A Sulfacetamide Sodium Topical Suspension USP, 10% (November 7, 2005) Page 2 of 4
SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: Adequate 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. Store at controlled room temperature 20潞鈥?25潞C
(68潞鈥?77潞F). Avoid heat, light, oxidants and bases.
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: General ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For external use
only. Keep away from eyes. (See package insert.)
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: Avoid heat, light, oxidants and bases.
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: 0168-0382-02
0168-0382-04
M SDS# 05A Sulfacetamide Sodium Topical Suspension USP, 10% (November 7, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Color: A cloudy, off-white to straw-colored, slightly viscous liquid.
M olecular W eight: Not applicable.
pH: ~ 6.5
Refractive Index @ 20潞C: Not determined.
Viscosity @ 25潞C: 100 - 2,500 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20潞C): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Disperses.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Specific Gravity @ 25潞C: ~ 1.1
% Volatile by Volume: ~ 87% as water
Evaporation Rate (Ether=1): Not indicated.
Date of Preparation/Change: Revision # 0 Replaces
November 7, 2005 None
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 Sulfacetamide Sodium Topical Suspension USP, 10% (November 7, 2005) Page 4 of 4
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