DERMOTIC EAR & SKIN SUSPENSION

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
POLYMYXIN B SULFATE; PREDNISOLONE ACETATE; MICONAZOLE NITRATE
Available from:
TROY LABORATORIES PTY LTD
INN (International Name):
miconazole as nitrate(20mg/mL)+prednisolone as acetate(4.1mg/mL) + others
Pharmaceutical form:
MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL
Composition:
POLYMYXIN B SULFATE ANTIBIOTIC Active 0.696 mg/ml; PREDNISOLONE ACETATE STEROID-GLUCOCORTICOID Active 5.0 mg/ml; MICONAZOLE NITRATE TRIAZOLE Active 23.0 mg/ml
Units in package:
20mL; 30mL; 40mL
Class:
VM - Veterinary Medicine
Manufactured by:
TROY LABORATORIES
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
EAR,NOSE,THROAT PREPS.
Therapeutic indications:
INFECTIONS OF THE SKIN | OTITIS EXTERNA | ABSCESSES | ACUTE CANINE OTITIS | ANAL SACCULITIS | ASSOCIATED WITH YEAST &/OR BAC | CHRONIC CANINE OTITIS | FUNGAL | GINGIVITIS | GRAM NEGATIVE BACTERIA | GRAM POSITIVE BACTERIA | MALASSEZIA PACHYDERMATIS | OTITIS (CANINE) | POST-PARTURIENT INFECTIONS | PYODERMA | SEPTICAEMIA | YEAST
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: Horses: Nil.; Host/pest details: CAT: [INFECTIONS OF THE SKIN, OTITIS EXTERNA]; DOG: [INFECTIONS OF THE SKIN, OTITIS EXTERNA]; HORSE: [INFECTIONS OF THE SKIN, OTITIS EXTERNA]; For the treatment of otitis externa and skin infections caused by fungi, yeasts, gram negative and gram positive bacteria in horses, dogs, and cats.
Authorization status:
Registered
Authorization number:
53950
Authorization date:
2019-07-01

102mm

40mm

PMS 338 C

PMS BLACK

FOIL SILVER

File Name: 53950_45654_20mL_LABEL_MPL_V1

Size: 102x40mm

Date: 24 March 09

Scale: A4 = 100% to scale

20mL

DIRECTIONS FOR USE Shake well

before use. Dermotic Ear & Skin

Suspension is not active against ear mites.

Otitis Externa: Instil 3-5 drops into the ear

twice daily. Gently massage the ear to

ensure even distribution of the product.

Skin Infections: Apply to the affected area

and rub in. After the clinical signs have

completely disappeared, continue treatment

without interruption for several days. In

certain obstinate cases, it may be

necessary to continue treatment for 2-3

weeks. At the beginning of treatment, cut

the hair surrounding or covering lesions.

LI0042_2

ACTIVE CONSTITUENTS:

23mg/mL Miconazole nitrate (equiv. to 20mg/mL Miconazole)

5mg/mL Prednisolone acetate (equiv. to 4.1mg/mL Prednisolone)

0.696mg/mL Polymyxin B sulphate (equiv. to 0.648mg/mL Polymyxin B)

For the treatment of otitis externa and skin

infections caused by fungi, yeasts, Gram-negative and

Gram-positive bacteria in horses, dogs and cats.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

MEAT WITHHOLDING PERIOD (HORSES): NIL

FIRST AID If poisoning occurs, contact a doctor

or Poisons Information Centre.

Phone Australia 131 126

TROY LABORATORIES PTY. LIMITED

98 LONG ST. SMITHFIELD, NSW 2164 AUSTRALIA

Dispose of empty container by wrapping with

paper and putting in the garbage.

Store below 25°C (Air conditioning).

APVMA Approval No.: 53950/20ML/0209

Batch:

Expiry:

SPOT COLOUR 3

APPROVED

LABEL

Info

pest

Verified

125mm

40mm

PMS 338 C

PMS BLACK

FOIL SILVER

File Name: 53950_45654_40mL_LABEL_MPL_V1

Size: 125x40mm

Date: 24 March 09

Scale: A4 = 100% to scale

40mL

DIRECTIONS FOR USE Shake well

before use. Dermotic Ear & Skin

Suspension is not active against ear mites.

Otitis Externa: Instil 3-5 drops into the ear

twice daily. Gently massage the ear to

ensure even distribution of the product.

Skin Infections: Apply to the affected area

and rub in. After the clinical signs have

completely disappeared, continue treatment

without interruption for several days. In

certain obstinate cases, it may be

necessary to continue treatment for 2-3

weeks. At the beginning of treatment, cut

the hair surrounding or covering lesions.

LI0032_1

ACTIVE CONSTITUENTS:

23mg/mL Miconazole nitrate (equiv. to 20mg/mL Miconazole)

5mg/mL Prednisolone acetate (equiv. to 4.1mg/mL Prednisolone)

0.696mg/mL Polymyxin B sulphate (equiv. to 0.648mg/mL Polymyxin B)

For the treatment of otitis externa and skin

infections caused by fungi, yeasts, Gram-negative and

Gram-positive bacteria in horses, dogs and cats.

MEAT WITHHOLDING PERIOD (HORSES): NIL

FIRST AID If poisoning occurs, contact a doctor

or Poisons Information Centre.

Phone Australia 131 126

TROY LABORATORIES PTY. LIMITED

98 LONG ST. SMITHFIELD, NSW 2164 AUSTRALIA

Dispose of empty container by wrapping with

paper and putting in the garbage.

Store below 25°C (Air conditioning).

APVMA Approval No.: 53950/40ML/0209

Batch:

Expiry:

SPOT COLOUR 3

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APPROVED

LABEL

MATERIAL SAFETY DATA SHEET

Product Name: Dermotic Ear & Skin Suspension

Page: 1 of 4

This revision issued: July, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 1 - Identification of The Material and Supplier

Troy Laboratories Australia Pty. Ltd

ABN: 21 000 283 769

Tel:

(02)9677 9000

31-35 Glendenning Road

Fax:

(02) 9677 9300

Glendenning NSW 2761

Chemical nature:

Multipurpose preparation - includes antibiotic and fungal ingredients.

Trade Name:

Dermotic Ear & Skin Suspension

Product Use:

For the treatment of certain skin infections in horses, cats and dogs as indicated on

the product label.

Creation Date:

June, 2005

This version issued:

July, 2010

and is valid for 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of SWA Australia.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

Not Hazardous - No criteria found.

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

Emergency Overview

Physical Description & Colour

: Thick white oily suspension.

Odour:

Mild odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Potential Health Effects

One of the ingredients is an antibiotic. Any person with a history of allergies to this class of substances

should avoid all contact with this product as it may cause sensitisation.

Inhalation

Short Term Exposure:

Significant inhalation exposure is considered to be unlikely. Available data indicates that

this product is not harmful. In addition product is unlikely to cause any discomfort or irritation.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: Exposure via eyes is considered to be unlikely. This product may be mildly irritating to

eyes, but is unlikely to cause anything more than mild discomfort which should disappear once product is removed.

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. This product is unlikely to cause any

irritation problems in the short or long term.

Long Term Exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Product Name: Dermotic Ear & Skin Suspension

Page: 2 of 4

This revision issued: July, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Miconazole nitrate

22832-87-8

23mg/mL

not set

not set

Prednisolone acetate

52-21-1

5mg/mL

not set

not set

Polymyxin B sulfate

1405-20-5

0.695mg/mL

not set

not set

Other non hazardous ingredients

to 100

not set

not set

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardous ingredients are also possible.

The TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a 5

day working week. The STEL (Short Term Exposure Limit) is an exposure value that should not be exceeded for more than 15 minutes and should

not be repeated for more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL. The term "peak "is

used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

Section 4 - First Aid Measures

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated by

this product. The number is 13 1126 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all

times. Have this MSDS with you when you call.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Irritation is unlikely. However, if irritation does occur, flush with lukewarm, gently flowing water for 5

minutes or until chemical is removed.

Eye Contact:

No effects expected. If irritation does occur, flush contaminated eye(s) with lukewarm, gently flowing

water for 5 minutes or until the product is removed. Obtain medical advice if irritation becomes painful or lasts more

than a few minutes.

Ingestion:

If product is swallowed or gets in mouth, wash mouth with water and give some water to drink. If

symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

: This product is classified as a C2 combustible product. There is no risk of an

explosion from this product under normal circumstances if it is involved in a fire. Violent steam generation or eruption

may occur upon application of direct water stream on hot liquids.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media

: Preferred extinguishing media are carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Major Ingredient Flashes About 180°C

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Flammability Class:

Section 6 - Accidental Release Measures

Accidental release

: In the event of a major spill, prevent spillage from entering drains or water courses. As a

minimum, wear overalls, goggles and gloves. Suitable materials for protective clothing include rubber, PVC. If there is

a significant chance that vapours or mists are likely to build up in the cleanup area, we recommend that you use a

respirator. Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned below (section 8).

Stop leak if safe to do so, and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material. If spill

is too large or if absorbent material is not available, try to create a dike to stop material spreading or going into drains

or waterways. Sweep up and shovel or collect recoverable product into labelled containers for recycling or salvage,

and dispose of promptly. Can be slippery on floors, especially when wet. Recycle containers wherever possible after

careful cleaning. After spills, wash area preventing runoff from entering drains. If a significant quantity of material

enters drains, advise emergency services. This material may be suitable for approved landfill. Ensure legality of

disposal by consulting regulations prior to disposal. Thoroughly launder protective clothing before storage or re-use.

Advise laundry of nature of contamination when sending contaminated clothing to laundry.

Product Name: Dermotic Ear & Skin Suspension

Page: 3 of 4

This revision issued: July, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 7 - Handling and Storage

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check

Section 8 of this MSDS for details of personal protective measures, and make sure that those measures are followed.

The measures detailed below under "Storage" should be followed during handling in order to minimise risks to

persons using the product in the workplace. Also, avoid contact or contamination of product with incompatible

materials listed in Section 10.

Storage

: Note that this product is combustible and therefore, for Storage, meets the definition of Dangerous Goods

in some states. If you store large quantities (tonnes) of such products, we suggest that you consult your state's

Dangerous Goods authority in order to clarify your obligations regarding their storage.

Store packages of this product in a cool place. Store in the closed original container in a dry, cool, well-ventilated area

out of direct sunlight. Make sure that the product does not come into contact with substances listed under

"Incompatibilities" in Section 10. Some liquid preparations settle or separate on standing and may require shaking

before use. Check packaging - there may be further storage instructions on the label.

Section 8 - Exposure Controls and Personal Protection

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the known significant ingredients in this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are

for bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that

the work environment remains clean and that vapours and mists are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt,

wear suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products, especially

when they contain antibiotics and that you wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

There is no specific recommendation for any particular protective material type.

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult

the Australian Standard mentioned above.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Thick white oily suspension.

Odour:

Mild odour.

Boiling Point:

Not available.

Freezing/Melting Point:

No specific data. Liquid at normal temperatures.

Volatiles:

No specific data. Expected to be low at 100°C.

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

No data. Expected to be about 0.9

Water Solubility:

Negligible.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

No data.

Section 10 - Stability and Reactivity

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have

any doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

This product should be kept in a cool place, preferably below 25°C. Store in the closed

original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

strong acids, strong bases, strong oxidising agents.

Product Name: Dermotic Ear & Skin Suspension

Page: 4 of 4

This revision issued: July, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Troy Laboratories Australia Pty Ltd

Phone: 02 9677 9000

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Fire Decomposition:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Water.

Carbon monoxide poisoning produces headache, weakness, nausea, dizziness, confusion, dimness of vision,

disturbance of judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

Local Effects:

Target Organs:

none known

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS database is present in this product at hazardous concentrations.

Section 12 - Ecological Information

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

Section 13 - Disposal Considerations

Disposal:

Containers should be emptied as completely as practical before disposal. If possible, recycle containers

either in-house or send to recycle company. If this is not practical, send to a commercial waste disposal site. This

product should be suitable for incineration. Please do NOT dispose into sewers or waterways.

Section 14 - Transport Information

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary

unless required by other regulations.

Section 15 - Regulatory Information

AICS:

All of the significant ingredients in this formulation are to be found in the public AICS Database.

The following ingredients: Miconazole, Polymyxin, Prednisolone are mentioned in the SUSDP.

Section 16 - Other Information

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail, 7th Edition

AICS

Australian Inventory of Chemical Substances

CAS Number

Chemical Abstracts Service Registry Number

IARC

International Agency for Research on Cancer

SWA

Safe Work Australia, formerly ASCC and NOHSC

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND

HOW TO SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF

HOW THE PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE,

THE USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT

TO OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “National Code of Practice for the Preparation of

Material Safety Data Sheets” 2nd Edition [NOHSC:2011(2003)]

Copyright © Kilford & Kilford Pty Ltd, July, 2010.

http://www.kilford.com.au/

Phone (02)9251 4532

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