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) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Alclometasone Dipropionate Cream USP, 0.05%
Synonyms: None.
CAS #: None.
Chemical Family: Topical Steroid.
Formula: Alclometasone Dipropionate USP, Propylene Glycol USP, White Petrolatum USP, Cetostearyl Alcohol NF, Glyceryl
Monostearate, PEG 100 Stearate, Ceteth-20, Monobasic Sodium Phosphate USP, Chlorocresol NF, Phosphoric Acid
USP and Purified Water USP.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 0 Minimal 0
Reactivity: 0 Slight 1
Environment (Air-Water-Soil): 0鈥?1鈥?1 Moderate 2
Special Hazards: Not indicated. 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. 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
Alclometasone Dipropionate 66734-12-2 0.05 no no no not established
Propylene Glycol 57-55-6 no no no not established
White Petrolatum 8009-03-8 no no no not established
Cetostearyl Alcohol 8005-44-5 no no no not established
10mg/m3* not established
Glyceryl Monostearate 31566-31-1 no no no
10mg/m3* not established
PEG 100 Stearate 9004-99-3 no no no
Ceteth-20 9004-95-9 no no no not established
Monobasic Sodium Phosphate 10049-21-5 no no no not established
Chlorocresol 59-50-7 no no no not established
1mg/m3 1mg/m3
Phosphoric Acid 7664-38-2 no no no
Purified Water 7732-18-5 no no no not established
* stearates
M SDS# 05A Alclometasone Dipropionate Cream USP, 0.05% (November 3, 2005) 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 Media: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: Use self-contained breathing apparatus when firefighting.
Unusual Fire and Explosion Hazards: May 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 Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] May Occur [ X ] Will Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. May cause reversible suppression of hypothalamic-pituitary-adrenal (HPA) axis, manifestations
of Cushing鈥檚 syndrome, hyperglycemia and glucosuria. May cause allergic reaction and skin
irritation in sensitive individuals.
b. Chronic Effects: b. Systemic absorption may cause effects similar to overexposure.
1. Inhalation: 1. None expected under normal condition of use.
2. Eyes: 2. May cause irritation. Not for ophthalmic use.
3. Skin: 3. May cause irritation. For topical use only.
4. Ingestion: 4. May result in absorption of corticosteroid. May induce low toxicity.
5. Medical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction. Sensitivity to corticosteroids or
Potentially Aggravated: imidazoles or any ingredient in this preparation.
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 2N鈥?30NC
Handling/Storage: (36N鈥?86NF). Avoid heat, light, oxidants and bases.
Hygienic Practices: Wash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
When Material is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove. Wash area
with soap and water. Dispose of in accordance with federal, state and local regulations.
Waste Disposal Methods: Assure conformity with applicable disposal regulations. Dispose of absorbed material at
approved incineration or chemical landfill waste disposal site.
SECTION 9: SPECIAL PROTECTION INFORMATION
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# 05A Alclometasone Dipropionate Cream USP, 0.05% (November 3, 2005) Page 2 of 4
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container closed when not in use. Store at controlled room temperature 2N鈥?30NC
(36N鈥?86NF). Avoid light, heat, 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: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without a prescription. For dermatologic use only. Not
for ophthalmic use. (See package insert.)
Warning Placard: Keep out of reach of children.
IMO Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from heat, light, oxidants and bases.
SECTION 11: ENVIRONMENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORMATION
Refer to the following references: OSHA Regulations: If respirator used, 29 CFR 1910.134
DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0263-15
0168-0263-45
0168-0263-60
M SDS# 05A Alclometasone Dipropionate Cream USP, 0.05% (November 3, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance: A white to off-white smooth and homogeneous cream
Molecular Weight: Not applicable.
pH: ~ 4.5
Refractive Index @ 20oC: Not determined.
Viscosity @ 25NC: 50,000鈥?300,000 cps
Boiling Point: Not determined.
Freezing/Melting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in Water: Disperses in warm water.
Solubility in Alcohol: Not indicated.
Solubility in Oil: Not indicated.
Solubility in Other: Not indicated.
Specific Gravity (H2O=1): ~0.85 @ 50NC
% Volatile by Volume: ~35% (as water)
Evaporation Rate (Ether=1): Not indicated.
Date of Preparation/Change: Revision # 0 Replaces
November 3, 2005 N/A
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 Alclometasone Dipropionate Cream USP, 0.05% (November 3, 2005) Page 4 of 4
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