SDS Number 127717 Approved/Revised 15-Mar-2005 Version 03
Material OTOMIZE EARSPRAY
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material OTOMIZE EARSPRAY
OTOMIZE EAR SPRAY (UK AND IRELAND) * FORMULA NUMBER IB 0537 *
Synonyms
DEXAMETHASONE AND NEOMYCIN SULPHATE, 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
NEOMYCIN SULFATE 0.6
1405-10-3
DEXAMETHASONE 0.1
50-02-2
ACETIC ACID 2
64-19-7
NON-HAZARDOUS INGREDIENTS 97.3
Unassigned
3. HAZARDS IDENTIFICATION
This product is classified as non-flammable.
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
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SDS Number 127717 Approved/Revised 15-Mar-2005 Version 03
Material OTOMIZE EARSPRAY
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 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 leakage of this material occurs, contain and collect 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
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 are considered necessary for the control of fire
and explosion hazards.
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SDS Number 127717 Approved/Revised 15-Mar-2005 Version 03
Material OTOMIZE EARSPRAY
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
NEOMYCIN SULFATE
INGREDIENT
1
GSK Occupational
Hazard Category
SKIN SENSITISER, RESPIRATORY
GSK Occupational 2000 mcg/m3 (8 HR TWA)
SENSITISER
Exposure Limit
Other Equipment or None required for normal handling. Wash hands and arms thoroughly after
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Solution.
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.
Skin Effects Irritation is not expected following direct contact.
Eye Effects Irritation is not expected following direct contact with eyes.
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.
* Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary No information is available about the potential of this product to produce
adverse environmental effects. Local regulations and procedures should be
consulted prior to environmental release.
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.
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SDS Number 127717 Approved/Revised 15-Mar-2005 Version 03
Material OTOMIZE EARSPRAY
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 Exempt when packaged for sale to consumers in a retail establishment.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 15-Mar-2005 SDS Version Number 3
SDS Sections Updated
Sections Subsections
HANDLING AND STORAGE General Requirements
Handling
Ignition Controls
Protective Systems
Storage
REGULATORY INFORMATION European Union Classification and Labelling
Requirements
Other Regulations
Other US Regulations - California Proposition 65
Other US Regulations - TSCA Status
State Regulations
Summary
US Environmental (EPA) Requirements
US OSHA Standard (29 CFR Part 1910.1200) -
Classification
US OSHA Standard (29 CFR Part 1910.1200) -
Target Organ Stat
TOXICOLOGY INFORMATION Inhalation Toxicity
Other Adverse Effects
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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