SDS Number 128688 Approved/Revised 15-May-2007 Version 4
VERAMYST NASAL SPRAY
Material



SAFETY DATA SHEET




1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material VERAMYST NASAL SPRAY
VERAMYST NASAL SPRAY 0.05% W/W * AVAMYS NASAL SPRAY *
Synonyms
ALLERMIST NASAL SPRAY * GW685698X INTRANASAL SPRAY * NDC NO:
0173-0753-00 * FLUTICASONE FUROATE, FORMULATED PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response

GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response

2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
FLUTICASONE FUROATE 0.05 to 0.2
397864-44-7
NON-HAZARDOUS INGREDIENTS 99.8 to 99.95
Unassigned

3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Handling this product in its final form presents minimal risk from
occupational exposure.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.

4. FIRST-AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the exposed subject is unconscious or semi-conscious. Wash
out the mouth with water. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.

SDS Number 128688 Approved/Revised 15-May-2007 Version 4
VERAMYST NASAL SPRAY
Material


Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Medical treatment in cases of overexposure should be treated as an
overdose of glucocorticosteroid. Treat according to locally accepted
protocols. For additional guidance, refer to the current prescribing
information or to the local poison control information centre.
Medical Conditions None for occupational exposure.
Caused or Aggravated
by Exposure
Antidotes No specific antidotes are recommended.

5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media No special requirements needed.
Special Firefighting For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
corrosive or flammable vapours might be evolved from fires involving this
product and associated packaging, self contained breathing apparatus and
full protective equipment are recommended for firefighters.
If possible, contain and collect firefighting water for later disposal.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures

7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION


SDS Number 128688 Approved/Revised 15-May-2007 Version 4
VERAMYST NASAL SPRAY
Material



FLUTICASONE FUROATE
INGREDIENT
4
GSK Occupational
Hazard Category
SKIN
GSK Occupational 6 mcg/m3 (8 HR TWA)
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures

9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
White.
Colour
Suspension.
Physical Form

10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.

11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity Adverse effects might occur following inhalation.
Skin Effects Irritation is not expected following direct contact. Recurrent repeated
contact with some steroids during manufacture or packing may lead to a
rash which appears when exposure to the steroid ceases (e.g. when on
holiday) and disappears on re-exposure to the substance.
Eye Effects Irritation is not expected following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: immune system; adrenal glands.
Sensitisation Sensitisation (allergic skin reaction) is not expected.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
selective glucocorticoid receptor agonist.
Other Adverse Effects None known for occupational exposure.

12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no environmental effects have been identified. Specific
information on the active pharmaceutical ingredient is provided below.
Local regulations and procedures should be consulted prior to
environmental release.
ECOTOXICITY
Aquatic




SDS Number 128688 Approved/Revised 15-May-2007 Version 4
VERAMYST NASAL SPRAY
Material


Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 1000 mg/l, 3 Hours, Activated sludge, Nominal
NOEC: 1000 , 3 Hours, Activated sludge, Nominal
Daphnid No toxicity to daphnids was observed for the active pharmaceutical
ingredient in this mixture, but the upper range of the test was limited by the
low water solubility of this compound.
EC50: > 4.2 mg/l, 48 Hours, Daphnia magna, Static
renewal test
NOEL: 4.2 mg/l, 48 Hours, Daphnia magna, Static renewal
test
Terrestrial
Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Eisenia foetida, manure worm
EC50: > 1000 mg/kg, 14 Days, Measured
NOEL: 1000 mg/kg, 14 Days,
MOBILITY
Solubility This mixture contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
Adsorption This mixture contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. This mixture contains an active pharmaceutical
ingredient that is likely to adsorb to sludges and other biomass.
Soil Sediment Sorption 3.6, Calculated
(log Koc):
Partitioning This mixture contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Biodegradation This mixture contains an active pharmaceutical ingredient that is not readily
nor inherently biodegradable (as defined by 1993 OECD Testing
Guidelines) and may persist in the environment. This mixture contains an
active pharmaceutical ingredient that slowly undergoes biodegradation in
soil.
Aerobic - Inherent
Percent Degradation: 0 %, 28 days, Modified MITI (II) Test., Activated
sludge
Aerobic - Soil
Percent Degradation: 2 to 3 %, 64 days, , Soil
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.



SDS Number 128688 Approved/Revised 15-May-2007 Version 4
VERAMYST NASAL SPRAY
Material



14. TRANSPORT INFORMATION
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only
authorised persons trained and competent in accordance with appropriate national and international
regulatory requirements may prepare dangerous goods for transport.
UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US
or European ground transport purposes.

15. REGULATORY INFORMATION
The information included below is an overview of the major regulatory requirements. It should not be
considered to be an exhaustive summary. Local regulations should be consulted for additional requirements.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This product is classified as hazardous according to the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt

16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-May-2007 SDS Version Number 4


SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AN OF COMPANY
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate
as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the
responsibility of the user to determine the applicability of this information and the suitability of the material
or product for any particular purpose.






FLUTICASONE FUROATE