SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material FLONASE NASAL SPRAY
FLIXONASE ALLERGY (UK) * FLONASE NASAL SPRAY 0.05% * FLONASE
Synonyms
AQUEOUS NASAL SPRAY 50MCG * FLIXONASE AQUEOUS NASAL SPRAY
50 MCG * FLUTINASE MICRODOSEUR * FLIXONASE ACUOSO NASAL *
FLIXONASE ACUOSO SPRAY NASAL * FLIXONASE AEROSOL NASAL *
FLIXONASE AEROZOL DO NOSA * FLIXONASE AKOZ NAZAL SPREY *
FLIXONASE AQUA NASAL SPRAY * FLIXONASE AQUOSUM NASENSPRAY
* FLIXONASE DEGUNA AEROSOL * FLIXONASE NAESESPRAY *
FLIXONASE NASAL AQUOSO * FLIXONASE NASAL SPREY * FLIXONASE
NAZALNI SPREJ * FLIXONASE NENASUMUTE * FLIXONASE NEUSSPRAY *
FLIXONASE NINAVESIPIHUSTI * FLIXONASE ORRSPRAY * FLIXONASE
PRSILO ZA NOS * FLIXONASE SUSPENSION NASALE * FLIXONASE
SUSPENSION, NEBULIZADOR NASAL * FLIXONASE VODNY NOSNI SPREJ
* BREXONASE INHALADOR NASAL * NDC NO 0173-0472-00 * NDC NO
0173-0453-01 * NDC NO 0173-0704-00 * FLUTICASONE PROPIONATE,
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
2200 Renaissance Blvd, Suite 105
King of Prussia, PA 19406 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 PROPIONATE 0.05
80474-14-2
NON-HAZARDOUS INGREDIENTS 99.95
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
Fire and Explosion
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SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
Health Caution - Potent pharmaceutical agent.
Health effects information is based on hazards of components.
May cause steroid withdrawal rash.
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.
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 Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre. Medical treatment in cases of overexposure should be
treated as an overdose of glucocorticosteroid.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product.
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 Water, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
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 Prevent entry into waterways, sewers, surface drainage systems and poorly
ventilated areas.
Clean-up Methods Spread an inert absorbent on the spill and place in a suitable, properly
labelled container for recovery or disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product.
Procedures
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SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
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
FLUTICASONE PROPIONATE
INGREDIENT
4
GSK Occupational
Hazard Category
SKIN
GSK Occupational 3 mcg/m3 (8 HR TWA)
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Suspension.
Physical Form
Bottle.
Packaging
6 to 6.8
pH of Aqueous Solutions
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.
Skin Effects Irritation is not expected following direct contact. Pharmacological effects
may occur following skin absorption.
Eye Effects Minor irritation might occur following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: adrenal glands; immune system.
Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment
based upon information from human exposure.
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.
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SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This material is a selective glucocorticoid receptor agonist.
Adverse effects of overexposure might include: suppression of adrenal
glands; temporary decrease in white blood cell counts; symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing);
increased susceptibility to infection.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
* Summary This material contains an active pharmaceutical ingredient that has had
limited testing and no adverse environmental effects were observed in the
tests conducted. There is insufficient information to determine the scope of
the environmental effects this material may cause. Until there is additional
testing to determine other potential adverse effects on the environment,
appropriate precautions should be taken to limit release of this compound to
the environment. Local regulations and procedures should be consulted
prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided
below.
ECOTOXICITY
Aquatic
* 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
* 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: > 0.55 mg/l, 48 Hours, Daphnia magna, Static test
Terrestrial
* Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic
to earthworms.
Eisenia foetida, manure worm
EC50: > 1000 mg/kg, 28 Days,
MOBILITY
* Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has very low solubility in water.
* Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into the air from hard surfaces or from a container of the pure
substance.
* Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. This material contains an active pharmaceutical
ingredient that is likely to adsorb to sludges and other biomass.
Soil Sediment Sorption 3.41 to 3.83, Measured
(log Koc):
Sludge Biomass 3.13 to 3.55 Estimated
Distribution Coefficient
(log Kd):
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SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
* Partitioning This material 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.
Half-Life, Neutral: > 1 Years, Measured
* Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Ready
Percent Degradation: < 44 %, 28 days
Aerobic - Soil
Percent Degradation: 9 to 50 %, 64 days
* BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
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.
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. For waste disposal purpose, this product should be
classified in line with the European Waste Catalogue criteria.
US OSHA Standard (29 CFR Part 1910.1200)
Classification Exempt when packaged for sale to consumers in a retail establishment.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
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SDS Number 110556 Approved/Revised 22-Nov-2004 Version 12
Material FLONASE NASAL SPRAY
Date Approved/Revised 22-Nov-2004 SDS Version Number 12
SDS Sections Updated
Sections Subsections
ECOLOGICAL INFORMATION Activated Sludge Respiration
Adsorption
Algal
Algal Degradation
Bioaccumulation
Biodegradation
Daphnid
Distribution
Earthworm
Ecotoxicity
Fish
Hydrolysis
Microbial Growth Inhibition
Microtox
Mobility
Other Adverse Effects
Other Species - Aquatic
Other Species - Terrestrial
Partitioning
Persistence/Degradation
Photolysis
Solubility
Summary
Volatility
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.
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