OTOMAX OINTMENT

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

Buy It Now

Active ingredient:
GENTAMICIN SULFATE; CLOTRIMAZOLE; BETAMETHASONE VALERATE
Available from:
Intervet Australia Pty Limited
INN (International Name):
gentamicin(2640IU/mL)+betamethasone as valerate(0.88mg/mL) + others
Pharmaceutical form:
TOPICAL CREAM, OINTMENT, PASTE, GEL, LOTION
Composition:
GENTAMICIN SULFATE ANTIBIOTIC Active 2640.0 IU/ml; CLOTRIMAZOLE IMIDAZOLE Active 8.8 mg/ml; BETAMETHASONE VALERATE STEROID-GLUCOCORTICOID Active 1.07 mg/ml
Units in package:
!12x7.5g; !tubes; *12x15g; *tubes; 12x14mLbot; 12x17mL; 14mL bot; 15g tube; 17mL; 240mL bot; 34mL bot; 6x34mL bot; 7.5g tubes
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
EAR,NOSE,THROAT + DERMAL
Therapeutic indications:
OTITIS EXTERNA | ACUTE CANINE OTITIS | ASSOCIATED WITH YEAST &/OR BAC | CHRONIC CANINE OTITIS | MALASSEZIA PACHYDERMATIS | OTITIS (CANINE)
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [OTITIS EXTERNA]; For the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.DO NOT use in animals with known perforation of the eardrum (tympanic membrane). DO NOT use in pregnant or lactating animals. DO NOT use concomitantly with drugs known to induce ototoxicity. NOT FOR USE in food producing animals.
Authorization status:
Registered
Authorization number:
51104
Authorization date:
2019-07-01

Registered

Product

Name:

OTOMAX

Ointment

Page 1

Pack

Sizes:

7.5g [15g, 14 mL, 34 mL, 240 mL,

x 7.5g,

Date (Version Control):

26/09/2013

x 14mL, 6 x 34 mL]

Description:

Primary

Carton

APVMA: 51104/58945

Panel labels,

text

above the

header

below

footer

included

this label text.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING

USING

FOR ANIMAL TREATMENT ONLY

OTOMAX®

Ointment

Approved

ACTIVE INGREDIENTS:

GENTAMICIN SULFATE equivalent to 2640

Gentamicin Base, 1.

07mg

ETHASONE VALERATE equivalent to 0.88

Betamethasone and 8.80 mg

CLOTRIMAZOLE per

For the treatment of canine acute and chronic otitis externa associat

with yeast

(Malassezia

pachydermatis)

and/or bacteria susceptible to gentamicin.

5g,14 mL, 34 mL, 240 mL, 12 x 7.

x 15g, 12 x 14mL, 6 x 34 mL]

MSD logo

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE:

Restraint

NOT FOR USE

food-producing

animals.

Contraindications

Contraindicated

animals

with

known

perforation

eardrum

(tympanic

membrane).

Contraindicated

use in

pregnant

lactating

animals.

Contraindicated

concomitant

with

drugs

known

induce

ototoxicity.

Precautions

If hyper-sensitivity to any component occurs, discontinue treatment and institute appropriate therapy.

Avoid

ncomitant use of drugs known

induce ototoxicity.

Administration

recommended doses

beyond 7 days may result in delayed wound healing.

Prolo

ed use or overdosage may produce

adverse immun

uppressive effect

Antibiotic susceptibility of the pathogenic organism(s) should be

determined prior to use of this preparation.

Dosage and

Administration

SHAKE

WELL

BEFORE USE.

oroughly clean and dry external ear.

ove foreign mater

l, crusted and d

debris etc. with a

non-irritating

solution.

ip excessi

hair from treatment area.

Examine ear

ensure

tympanic membrane

not ruptured.

Dogs less th

15kg: 4 dro

Dogs 15kg

8 drops.

stil twi

daily into ear canal.

Therapy

should continue for 7 consecutive days.

For further

information

contact

Animal

Health

Customer

Service

1 800 033 4

Zealand

Customer

Service

0800

543.

SAFETY DIRECTIONS

Will

irritate

eyes.

Avoid

contact

with

eyes.

product

eyes,

wash

immediately

with

water. Wash hands

after

use.

--------------------------------

Pagel

Registered

Product

Name:

OTOMAX

Oinlmenl

Page 2 of 6

Pack

Sizes:

7.5g [15g, 14 mL, 34

240 mL,

7.5g, 12

Date (Version Control):

26/09/2013

15g,

14mL, 6

34 mL]

Description: Primary Carton

APVMA: 51104/58945

Panel labels, text

above

the header and

belm,.,

the footer are

not

included in this label text.

FIRST AID

poisoning

occurs,

contact

doctor

Poisons

Information

Centre (Phone

Australia

131126)

New Zealand National

Poisons

Centre (Phone 0800

POISON-

0800 764 766).

Dispose

of empty container by wrapping with paper and putting

garbage.

Unused product should

be returned to a veterinarian.

Store below

25'C

(Air Conditioning).

panel

Batch

Expiry

APVMA Approval No.:

04/58945

MSD Animal Health

lntervet Australia Ply Ltd

91-105 Harpin St

Bendigo East Vic 3550

Ph: Customer Service 1800 033

New Zealand

Information

RESTRICTED VETERINARY MEDICINE

ACVM

A7883.

Registered to:

Schering-Piough Animal Health Ltd

Phone: 0800 800 543

www.msd-animal-health.co.nz

-----------------------------

Page2

Registered Product Name:

OTOMAX

Ointment

Page 3

of6

Pack

Sizes:

7.5g [15g,14

x 7.5g, 12 x

Date (Version Control):

15g,

14ml,

Description: Leaflet

APVMA:

51104/58945

Panel labels, text above the header and below the footer are not included in this label text.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH

CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

OTOMAX® Ointment

2610912013

ACTIVE

INGREDIENTS:

GENTAMICIN

SULFATE

equivalent

2640

Gentamicin

Base,

1.07mg

BETAMETHASONE

VALERATE

equivalent

0.88

Betamethasone

8.80

CLOTRIMAZOLE per

Indications:

For the treatment

canine acute

chronic otitis extema associated with yeast (Malassezia

pachydermatis)

and/or bacteria susceptible to gentamicin.

Pharmacology:

Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic gram-

negative

gram-positive bacteria.

In vitro

tests have determined that gentamicin is bactericidal

acts

inhibiting

normal

protein

synthesis

susceptible

microorganisms.

Specifically,

gentamicin

active

against

following

organisms

commonly

isolated

from

canine

ears:

Staphylococcus

intermedius,

other

coagulase-positive

Staphylococcus

spp.,

Pseudomonas

aeruginosa, Proteus

spp., and

Escherichia coli.

Betamethasone valerate is a synthetic adrenocorticoid for dermatologic use.

Betamethasone, an

analogue

of prednisolone,

a

high

degree

of corticosteroid

activity and

a

slight

degree

mineralocorticosteroid activity.

Betamethasone valerate, the 17-valerate ester

betamethasone, has

been

shown to

provide anti-inflammatory and

anti-pruritic activity

the topical

management

corticosteroid-responsive otitis externa.

Topical corticosteroids can be absorbed from normal, intact

skin.

Inflammation can increase percutaneous absorption.

Once absorbed through the skin, topical

corticosteroids are handled through pharmacokinetic pathways similar

systemically administered

corticosteroids.

Clotrimazole is

a

broad-spectrum antifungal agent that is used for the treatment of dermal infections

caused

by various

species

of pathogenic

dermatophytes

yeasts.

primary action

clotrimazole is against dividing and growing organisms.

vitro,

clotrimazole exhibits fungistatic and

fungicidal

activity

against

isolates

Trichophyton

rubrum,

Trichophyton

mentagrophytes,

Epidermophyton

floccosum,

Microsporum

canis,

Candida

spp.,

Malassezia

pachydermatis

(Pityrosporum

canis).

Resistance to clotrimazole

very rare among the fungi that cause superficial

mycoses.

studies of the mechanism

action, the minimum fungicidal concentration

clotrimazole

caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant

breakdown of cellular nucleic acids and accelerated potassium efflux.

These events began rapidly

and extensively after addition

the drug.

Clotrimazole is very poorly absorbed following dermal

application.

Restraint

NOT FOR USE

food-producing

animals.

Contraindications

Contraindicated

animals

with

known

perforation

eardrum

(tympanic

membrane).

Contraindicated

pregnant

lactating animals.

Contraindicated

concomitant

with

drugs

known

induce

ototoxicity.

-----------------------------

Page3

Registered

Product

Name:

OTOMAX

Ointment

Page 4

Pack

Sizes:

7.5g [15g, 14

34 m L, 240

x 7.5g, 12 x

Date (Version

Control)

: 26/09/2013

15g, 12 x

14ml,

6 x 34 m

Description: Leaflet

APVMA

: 51104/58945

Pane

l labels, text above

header

below the footer

included

this label text.

Precautions

hypersensitivity

component

occurs,

treatment

should

discontinued

appropriate

therapy

instituted.

Concomitant

drugs

known

induce

ototoxicity

should

be avoided.

Corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft

palate offspring.

Other congenital anomalies including deformed forelegs, phocomelia, and anasarca

have been reported in offspring

dogs which received corticosteroids during pregnancy.

Clinical and

experimental

data

have demonstrated that corticosteroids administered

orally or parenterally to

animals may induce the first stage of parturition if used during the last trimester

pregnancy and may

precipitate premature parturition followed by dystocia, foetal death, retained placenta and metritis.

Administration

recommended doses of OTOMAX beyond 7 days may result

delayed wound

healing. Adverse systemic reactions have been observed following the oral ingestion

some topical

corticosteroid

preparations.

Patients

should

closely

observed

usual

signs

adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight

gain,

polydipsia,

and/or

polyuria.

Prolonged

overdosage

produce

adverse

immunosuppressive effects.

Special

Precautions

Use:

Identification

fe cti

organisms should be made either by microscopic roll smear evaluation or by

culture

appropriate.

If overgrowth

of nonsusceptible

bacteria,

fungi

yeasts

occur,

hypersensitivity

develops, treatment should

discontinued

appropriate therapy

instituted.

Antibiotic susceptibility

pathogenic organism(s) should be determin

prior to use

this

preparation.

The use of OTOMAX® has been associated with deafness or parti

hearing loss in a small number

sensitive dogs (eg.

geriatric).

The hearing deficit is usually temporary.

If hearing or vestibular

dysfunction is noted during the course of treatment, discontinue use

OTOMAX® immediately and

flush the ear canal thoroughly with a non-ototoxic solution.

Undesirable Effects:

Gentamicin:

aminoglycosides are absorbed poorly from skin, intoxication may occur when

aminoglycosides are applied topically for prolonged periods of time to large wounds, burns

denuded skin, particularly if there is renal insufficiency.

All aminoglycosides have the potential to

produce reversible and irreversible vestibular, cochlear and renal toxicity.

Betamethasone:

Side effects such

SAP and SGPT enzyme elevations, weight loss, anorexia,

polydypsia

polyuria

have

occurred

following

of parenteral

systemic

synthetic

corticosteroids in dogs.

Vomiting and diarrhoea (occasionally bloody) have been observed

dogs.

corticosteroids, depending on dose and duration may result

endogenous steroid production

inhibition following drug withdrawal.

Cushing's syndrome

dogs has been reported

association

with prolonged or repeated steroid therapy.

Clotrimazole:

The following

ve been reported occasionally

humans in connection with the use

clotrimazole:

erythema, stinging, blistering, peeling, oedema,

pruritus, urticaria

general

irritation

the skin not present before therapy.

Dosage and

Administration:

SHAKE

WELL

BEFORE USE

The external ear should

thoroughly cleaned and dried before treatment.

Remove foreign material,

debris, crusted exudates etc. with suitable non-irritating solutions.

Excessive hair should be clipped

from the treatment area.

Page4

Registered Product Name:

OTOMAX

Ointment

Page 5

of

6

Pack

Sizes:

7.5g [15g,

x 7.5g,

Date (Version Control):

26/09/2013

15g,

14ml,

6 x 34

Description; Leaflet

APV:\olA:

51104/58945

Panel labels, text above the header and belo\y the footer are not included in this label

text.

Before instilling any medication into the ear, examine the external ear canal thoroughly

certain

the tympanic membrane is not ruptured

order

avoid the possibility of transmitting infection

middle ear

well

damaging the cochlea or vestibular apparatus from prolonged contact.

After verifying that the eardrum

intact, shake well and instill 4 drops twice daily into the ear canal

dogs weighing less than 15kg.

Instill 8 drops twice daily into the ear canal of dogs weighing 15kg

more.

Therapy should continue for 7 consecutive days. If hearing or vestibular dysfunction is noted

during the course of treatment, discontinue use of OTOMAX®,

For further

information

contact

MSD Animal Health

Customer

Service

1 800 033

Zealand

Customer

Service

0800 800 543.

FIRST AID

poisoning

occurs,

contact

doctor

Poisons

Information

Centre (Phone

Australia

131126)

New Zealand National

Poisons

Centre (Phone 0800

POISON-

0800 764 766).

SAFETY DIRECTIONS

Will

irritate the eyes.

Avoid

contact

with

eyes.

product

in eyes,

wash

immediately

with

water. Wash hands

after

use.

DISPOSAL

Dispose of empty container by wrapping with paper and putting

garbage.

Unused product should

returned

a veterinarian.

STORAGE

Store below 25°C (Air Conditioning).

WARRANTY

lntervet Australia Pty Ltd (IAPL), also known

MSD Animal Health, warrants that this product is of

merchantable quality and fit for

intended purpose.

IAPL's liability for any loss, including

consequential losses

injury caused by act or omission, including negligent acts or omissions, by

IAPL or its agent, is limited to replacing

repairing the product at the option of IAPL.

If possible, a

sample of any product causing concern should

retained or delivered to IAPL within

days for a

scientific examination.

APVMAApproval No.: 51104/58945

MSD Animal Health

lntervet Australia Pty Ltd

91-105 Harpin St

Bendigo East Vic 3550

Customer Service 1800 033

Registered Trademark

New Zealand Information

RESTRICTED VETERINARY MEDICINE

ACVM

A7883.

Registered

Schering-Piough Animal Health Ltd

Phone: 0800 800

www.msd-animal-health.co.nz

--~-------------------------PageS

Registered Product Name: OTOMAX Ointment

Page

Pack

Sizes:

7.5g [15g, 14 mL, 34 mL, 240 mL,

x 7.5g, 12 x

Date (Version Control):

26/09/2013

15g,

x 14mL, 6

Description: Immediate Container Label

APVMA:

51104/58945

Panel labels, text above the header and below the footer are not included

in

this label text.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH

CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

ANIMAL

TREATMENT ONLY

OTOMAX® Ointment

ACTIVE

INGREDIENTS:

GENTAMICIN

SULFATE

equivalent

2640

Gentamicin

Base,

1.07mg BETAMETHASONE

VALERATE

equivalent

0.88

Betamethasone

8.80

CLOTRIMAZOLE per

7.5g [15g,14 mL, 34

[MSD

Animal

Health

logo]

For the

treatment of canine acute and

chronic otitis externa associated with

yeast (Ma/assezia

pachydermatis)

and/or bacteria susceptible to gentamicin.

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Dispose

of empty container by wrapping with paper and putting

garbage.

Unused product should

be returned

a veterinarian.

Store below

25'C

(Air Conditioning).

APVMA No.: 51104158945

MSD Animal Health

lntervet Australia Ply Ltd

91-105 Harpin St

Bendigo East Vic 3550

Ph: Customer Service 1800 033

Information

ACVM

A7883.

EXP.

-------------------------------

Page6

Product Name: Otomax Ointment

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2009

Page: 1 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Substance:

Suspension of ingredients in water.

Trade Name:

Otomax Ointment

Recommended Use:

For the treatment of canine acute and chronic otitis externa associated with yeast and/or

bacteria susceptible to gentamicin.

APVMA No:

51104

Creation Date:

August, 2009

This version issued:

August, 2009

and is valid for 5 years from this date.

Statement of Hazardous Nature:

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

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

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S24/25. Avoid contact with skin and eyes.

SUSDP Classification:

ADG Classification:

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

UN Number:

None allocated

Physical Description & Colour:

A white to off white viscous suspension.

Odour:

no data.

Major Health Hazards:

no significant risk factors have been found for this product. This is an antibiotic preparation.

Any person with a history of allergies to this class of substances should avoid all contact with this product as it may cause

sensitisation. This is a physiologically active product and so contact should be minimised, especially if the user is taking a

form of medication, as interactions can sometimes give unexpected and undesired results.

Inhalation:

Short Term Exposure:

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. However product may be mildly irritating, but is unlikely to cause anything more than mild discomfort which

should disappear once contact ceases.

Long Term Exposure:

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

Potential Health Effects

Emergency Overview

Section 2 - Hazards Identification

Section 1 - Identification of Chemical Product and Company

Intervet Australia Pty Limited

91-105 Harpin Street

Tel: 1 800 033 461

Bendigo East, Vic 3550, AUSTRALIA

Fax: 1 800 817 414

Company ABN: 79 008 467 034

Product Name: Otomax Ointment

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2009

Page: 2 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Eye Contact:

Short Term Exposure

: 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. However, this product may be irritating

to mucous membranes but is unlikely to cause anything more than transient discomfort.

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.

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Betamethasone

2152-44-5

1g/kg

not set

not set

Clotrimazole

23593-75-1

10g/kg

not set

not set

Gentamicin sulfate

1405-41-0

3000 IU/g

not set

not set

Other non hazardous ingredients

secret

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 SWA 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 may be equalled (but should not be exceeded) for no longer than

15 minutes and should not be repeated 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.

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 11 26 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. Take special care if exposed person is wearing contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; 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.

Fire and Explosion Hazards:

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Only small quantities of decomposition products are expected from this products at temperatures normally achieved in a

fire. This will only occur after heating to dryness.

Fire decomposition products from this product are not expected to be hazardous or harmful.

Extinguishing Media

: Not Combustible. Use extinguishing media suited to burning materials.

Section 3 - Composition/Information on Ingredients

Section 4 - First Aid Measures

Section 5 - Fire Fighting Measures

Product Name: Otomax Ointment

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2009

Page: 3 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Fire Fighting

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

Flash point

:

Does not burn.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability Class:

Does not burn.

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, clean up, rinsing to sewer and put empty container in garbage. Although no

special protective clothing is normally necessary because of occasional minor contact with this product, it is good practice

to wear impermeable gloves when handling chemical products. In the event of a major spill, prevent spillage from entering

drains or water courses and call emergency services.

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

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage of

this schedule of poison. Protect this product from light. 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 stirring before

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

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 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 and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

We suggest that protective clothing be made from the following materials: rubber.

Respirator:

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

Australian Standard mentioned above.

Physical Description & Colour

A white to off white viscous suspension.

Odour:

no data.

Section 9 - Physical and Chemical Properties

Section 8 - Exposure Controls and Personal Protection

Section 7 - Handling and Storage

Section 6 - Accidental Release Measures

Product Name: Otomax Ointment

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2009

Page: 4 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Approximately 0°C.

Volatiles:

Water component.

Vapour Pressure:

2.37 kPa at 20°C (water vapour pressure).

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Completely soluble in water.

pH:

No data. Expected to be neutral.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

Not applicable - does not burn.

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:

Protect this product from light. 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.

Fire Decomposition:

Only small quantities of decomposition products are expected from this products at

temperatures normally achieved in a fire. This will only occur after heating to dryness. Carbon dioxide, and if combustion

is incomplete, carbon monoxide. Nitrogen and its compounds, and under some circumstances, oxides of nitrogen.

Occasionally hydrogen cyanide gas in reducing atmospheres. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and

other sulfur compounds. Most will have a foul odour. 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.

Local Effects:

Target Organs:

There is no data to hand indicating any particular target organs.

Ingredient

Risk Phrases

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

Insufficient data to be sure of status. Expected to not be an environmental hazard.

Disposal:

Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For larger

quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

Classification of Hazardous Ingredients

Section 10 - Stability and Reactivity

Section 11 - Toxicological Information

Section 12 - Ecological Information

Section 13 - Disposal Considerations

Product Name: Otomax Ointment

MATERIAL SAFETY DATA SHEET

This revision issued: August, 2009

Page: 5 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

ADG Code:

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

required by other regulations.

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredients: Betamethasone, Clotrimazole, Gentamicin sulfate, are mentioned in the SUSDP.

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 (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

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:2001(2003)]

Section 14 - Transport Information

Section 15 - Regulatory Information

Section 16 - Other Information

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