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
Emergency Telephone No.: (631) 454-7677
SECTION 1: IDENTITY
Product Name: Desonide Lotion, 0.05%
Synonyms: None.
CAS #: Not applicable.
Chemical Family: Topical steroid lotion.
Formula: Desonide, Sodium Lauryl Sulfate, Light M ineral Oil, Cetyl Alcohol, Stearyl Alcohol, Propylene Glycol,
M ethylparaben, Propylparaben, Sorbitan M onostearate, Glyceryl Stearate SE, Edetate Sodium, Citric
Acid Anhydrous and Purified W ater. M ay also contain additional Citric Acid USP and/or Sodium
Hydroxide NF for PH adjustment.
SECTION 2: SAFETY and HAZARD RATINGS
Health (Acute-Chronic): 1鈥?1 RATINGS
Flammability: 0 M inimal 0
Reactivity: 0 Slight 1
Environment (Air-W ater-Soil): 0鈥?1鈥?0 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
D esonide 638-94-8 0.05 no no no not established
Sodium L auryl Sulfate 151-21-3 no no no not established
L ight M ineral O il 8042-47-5 no no no not established
C etyl A lcohol 124-29-8 no no no not established
Stearyl A lcohol 112-92-5 no no no not established
P rop ylene G lycol 57-55-6 no no no not established
M ethylparaben 99-76-3 no no no not established
P ropylparaben 94-13-3 no no no not established
Sorbitan M onostearate 1338-41-6 no no no 10 m g/m 3* not established
G lyceryl Stearate SE 31566-31-1 no no no 10 m g/m 3* not established
E detate Sodium 64-02-8 no no no not established
C itric A cid A nhydrous 77-92-9 no no no not established
W ater 7732-18-5 no no no not established
Sodium H ydroxide 1310-73-2 no no no not established
* as stearates
M SDS# 05A Desonide Lotion, 0.05% (June 6, 2005) Page 1 of 4
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not indicated.
Auto-ignition Temperature oF: 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 when firefighting.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning, and may react with bases and oxidizers.
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: [ ] M ay Occur [ X ] Should Not Occur
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion, Inhalation.
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. M ay cause irritation to throat.
2. Eyes: 2. M ay cause irritation. Not for ophthalmic use.
3. Skin: 3. M ay cause irritation on prolonged contact. Systemic absorption may cause effects
4. Ingestion: similar to overexposure.
5. M edical Conditions 4. M ay cause hyperglycemia and glycosuria.
Potentially Aggravated: 5. Hypothalamic-pituitary-adrenal (HPA) axis dysfunction, skin irritation and allergy
in sensitive individuals.
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container closed when not in use. Do not handle or store near heat, flame or
oxidizers. Store between 2 o鈥?30 oC (36 o鈥?86 o F).
Handling/Storage:
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 Desonide Lotion, 0.05% (June 6, 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. Do not handle or store near heat,
flame, oxidizers, light, or bases. Store between 2 o鈥?30 oC (36 o鈥?86 o F).
Recommended Container: As supplied (not sold in bulk quantity).
Protect the Container by: Avoid physical damage, heat, flame and light.
Container Should be Handled in an Area with: Adequate general ventilation.
The Empty Container is: Not reusable.
Precautionary Label: Federal law prohibits dispensing without prescription. For dermatologic use
only. Not for ophthalmic use. (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: Keep away from heat, flame, oxidizers, light 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: 0168-0310-02
0168-0310-04
M SDS# 05A Desonide Lotion, 0.05% (June 6, 2005) Page 3 of 4
SECTION 13: PHYSICAL DATA
Appearance (and Odor): A white to off-white lotion with no discernible odor.
M olecular W eight: Not applicable.
pH: 5.0鈥?7.0
Refractive Index @ 20 oC: Not determined.
Viscosity @ 25 oC: 3,000鈥?12,000 cps
Boiling Point: Not determined.
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20 oC): 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 determined.
0.9鈥?1.0 @ 25 oC
Specific Gravity (H 2O=1):
% Volatile by Volume: ~ 78% (water)
Evaporation Rate (Ether=1): Not determined.
Date of Preparation/Change: Revision # 1 Replaces
June 6, 2005 M ay 10, 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 Desonide Lotion, 0.05% (June 6, 2005) Page 4 of 4
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