MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO.
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
Amcinonide Lotion, 0.1%
Product Name:
None indicated.
Synonyms:
Not applicable.
CAS #:
Topical corticosteroid.
Chemical Family:
Amcinonide, Benzyl alcohol, Emulsifying wax, Glycerin, Isopropyl palmitate, Lactic acid, Purified water,
Formula:
Sorbitol solution, Polyethylene Glycol 400, and Sodium hydroxide.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1-0 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0鈥?0鈥?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. 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
Amcinonide 51022-69-6 0.1 no no no not established
Benzyl alcohol 100-51-6 1.0 no no no not established
Emulsifying wax n/a no no no not established
10 mg/m3
Glycerin 56-81-5 no no no not established
Isopropyl palmitate 142-91-6 no no no not established
Lactic acid 50-21-5 no no no not established
Water 7732-18-5 no no no not established
Sorbitol 50-70-4 no no no not established
Polyethylene glycol 400 25322-68-3 no no no not established
Sodium hydroxide 1310-73-2 no no no not established
M SDS# 05A Amcinonide Lotion, 0.1% (December 12, 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 and protective clothing.
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: Heat, light, oxidants and bases.
Hazardous Combustion or Decomposition Products: Carbon dioxide, Carbon monoxide.
Hazardous Polymerization: [ ] M ay Occur [ X ] Should 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 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.
1. Inhalation: 1. Not expected under normal conditions of use.
2. Eyes: 2. Possible eye irritation. Not for ophthalmic use.
3. Skin: 3. M ay cause irritation. Systemic absorption may cause effects similar to
overexposure.
4. Ingestion: 4. M ay cause hyperglycemia and glycosuria.
5. M edical Conditions 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy
Potentially Aggravated: in sensitive individuals.
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: 15潞鈥?30潞C (59潞鈥?86潞F). DO NOT FREEZE. Do not handle or store neat 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: Avoid any ignition sources. Use non-sparking tools. Absorb on sand or vermiculite
and place in closed containers for disposal. Ventilate and wash area after material
pickup is complete, Report major leaks and spills to the appropriate local, state
and/or federal governmental agency.
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 Amcinonide Lotion, 0.1% (December 12, 2005) 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.
Store at controlled room temperature 15潞鈥?30潞C (59潞鈥?86潞F). DO NOT
FREEZE. Do not handle or store near 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: 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.)
W arning Placard: Flammable liquid. Keep out of the reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Store at controlled room temperature 15潞鈥?30潞C (59潞鈥?86潞F). DO NOT
FREEZE. Do not handle or store near 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 OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0280-60
M SDS# 05A Amcinonide Lotion, 0.1% (December 12, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance and Odor: A white-to-off white lotion with a slight odor.
M olecular W eight: Not applicable.
pH: ~ 4.5
Refractive Index @ 20潞C: Not determined.
Viscosity @ 25潞C: 750鈥?7,500 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 determined.
Solubility in Oil: Not determined.
Solubility in Other: Not indicated.
Specific Gravity (H 2O=1): 0.92鈥?1.04 @ 25潞C
% Volatile by Volume: ~ 80% (water)
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
December 12, 2005 December 2, 2002
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 Amcinonide Lotion, 0.1% (December 12, 2005) Page 4 of 4
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