APEX ANTIBIOTIC LOTION WITH ANTI-INFLAMMATORY, ANAESTHETIC & BITTERANT

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

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Active ingredient:
NEOMYCIN SULFATE; LIGNOCAINE HYDROCHLORIDE; HYDROCORTISONE; DENATONIUM BENZOATE
Available from:
Dechra Veterinary Products (Australia) Pty. Ltd.
INN (International Name):
neomycin sulfate(5mg/mL)+lignocaine HCl(10mg/mL) + others
Pharmaceutical form:
TOPICAL CREAM, OINTMENT, PASTE, GEL, LOTION
Composition:
NEOMYCIN SULFATE ANTIBIOTIC Active 5.0 mg/ml; LIGNOCAINE HYDROCHLORIDE CAINE Active 10.0 mg/ml; HYDROCORTISONE STEROID-GLUCOCORTICOID Active 5.0 mg/ml; DENATONIUM BENZOATE CARBAMATE Other 0.2 mg/ml
Units in package:
100 mL; 2.5 L; 50 mL
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
DERMATOLOGICAL PREPS.
Therapeutic indications:
DERMATOSES | INFECTIONS OF THE SKIN | PRURITIS | ABSCESSES | ALLERGIC SKIN DISORDER | ANAL SACCULITIS | FUNGAL | GINGIVITIS | GRAM NEGATIVE BACTERIA | GRAM POSITIVE BACTERIA | POST-PARTURIENT INFECTIONS | PYODERMA | SEPTICAEMIA | YEAST
Product summary:
Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT (HORSES): 28 days.; Host/pest details: CAT: [DERMATOSES, INFECTIONS OF THE SKIN, PRURITIS]; DOG: [DERMATOSES, INFECTIONS OF THE SKIN, PRURITIS]; HORSE: [DERMATOSES, INFECTIONS OF THE SKIN, PRURITIS]; For the topical treatment of skin infections caused by neomycin sensitive bacteria and pruritus and dermatoses responsive to corticosteroid therapy in dogs, cats and horses.
Authorization status:
Registered
Authorization number:
48412
Authorization date:
2020-07-01

For Official Use Only

e-Label Application (DRAFT)

Company Name:

APEX LABORATORIES PTY LTD

Product Name:

APEX ANTIBIOTIC LOTION WITH HYDROCORTISONE AND LIGNOCAINE

eLabel Application No:

DC13-37185715E43

APVMA Approval No:

48412/100562

Product No:

48412

Version No:

Application Started:

2014-Sep-26 12:44:09

Version Created:

2014-Nov-11 10:37:42

Started By:

Rebecca Skinner

Printed:

2014-Nov-11 11:20:47

Label Name:

APEX ANTIBIOTIC LOTION WITH HYDROCORTISONE AND LIGNOCAINE

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

5 mg/ml NEOMYCIN SULFATE

10 mg/ml LIGNOCAINE HYDROCHLORIDE

5 mg/ml HYDROCORTISONE

Claims:

For the topical treatment of skin infections caused by neomycin sensitive bacteria and

pruritus and dermatoses responsive to corticosteroid therapy in dogs, cats and horses.

Net Contents:

100mL

2.5L

50mL

Directions for Use:

Rub well into affected area daily or as directed by a veterinary surgeon.

Wear protective gloves during application or wash hands with soap and water after

application.

Withholidng

Periods:

MEAT WITHHOLDING PERIOD (HORSES): 28 days

First Aid

Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131

126.

First Aid Warnings:

Disposal:

Dispose of empty container by wrapping with paper and putting in garbage.

Storage:

Store below 30ºC (room temperature).

RLP

APPROVED

For Official Use Only

Name and Address:

Apex Laboratories Pty Ltd

61 Chivers Road. Somersby. NSW 2250

(02) 4372 1661

Material Safety Data Sheet

Antibiotic Lotion with Hydrocortisone and Lignocaine

Not classified as hazardous according to the criteria of NOHSC

Product Name

Antibiotic Lotion with Hydrocortisone and Lignocaine

Recommended Use

Treatment of skin infections and steroid responsive dermatoses in dogs,

cats and horses.

Supplier Details

Apex Laboratories Pty. Ltd.

ACN Number

000 397 240

Street

61 Chivers Road

Suburb

Somersby

State

Country

Australia

Post Code

2250

Phone

+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)

+61 2 4372 1668 (fax)

Website

http://www.apexlabs.com.au

Emergency contact

As above or Poisons Information Centre 131126 (Australia)

Classification

Not classified as hazardous according to the criteria of NOHSC

Risk Phrases

None allocated

Safety Phrases

None allocated

ADG Class

None allocated

Hazchem Code

None allocated

Poisons Schedule

Not Scheduled

Ingredients

CAS No

Proportion

TWA mg/m3

STEL mg/m3

Neomycin sulfate

1405-10-3

<10%

not set

not set

Hydrocortisone

50-23-7

<10%

not set

not set

Lignocaine HCl

6108-05-0

<10%

not set

not set

Cetomacrogol 1000

68439-49-6

<10%

not set

not set

Citric Acid

77-92-9

<10%

not set

not set

Denatonium Benzoate

3734-33-6

<10%

not set

not set

Other non hazardous ingredients

to 100%

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 over an entire working lifetime. The TWA exposure standard set by Worksafe Australia for dusts not otherwise specified is 10mg/m3. 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.

Ingestion

Generally not required. If concerned rinse mouth with water, give water to

drink and seek medical advice.

Irrigate with copious quantities of lukewarm water for 10 minutes and seek

medical advice.

Skin

Wash well with soap and water and if concerned seek medical advice.

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MSDS|Antibiotic Lotion with Hydrocortisone and Lignocaine

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/7/Antibiotic+Lotion+with+Hydrocortisone+and+Lignocaine/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION I Identification of the Material and Supplier

SECTION II Hazard Identification

SECTION III Composition

SECTION IV First Aid Measures

Inhalation

Generally not required. If concerned move to fresh air and seek medical

advice.

Extinguishing Media

Dry agent, water fog, mist or spray. As appropriate for surrounding

material.

Combustion Hazards

Toxic or irritating fumes may be released including carbon monoxide and

carbon dioxide.

Precautions for Firefighters

Wear self contained breathing apparatus and protective clothing.

Hazchem Code

None allocated

Emergency Procedures

Spillage of formulated product from marketed packaging is unlikely to ever

be serious, however, in the event of a major spill, protect drains and water

courses from contamination.

Materials and Methods

Wear protective clothing (overalls, gloves, goggles and boots). Shovel

spillage into clean, dry, labelled containers and dispose after consulting

appropriate authorities. Take care not to slip.

Precautions

Always use good occupational work practices and observe

recommendations on the label. Keep exposure to this product to a

minimum. Prohibit eating, drinking and smoking in storage and handling

areas. Wash hands after handling and remove contaminated clothing and

any protective equipment before entering eating areas.

Conditions

Store product in original containers as per label instruction (below 30oC or

room temperature).

National Exposure Standards

No exposure standard has been allocated for this mixture or any

significant ingredient within this mixture.

Biological Limit Values

No biological limit has been allocated for this mixture.

Engineering Controls

No specific engineering controls are required for this mixture.

Personal Protective Equipment

Eye protection is not normally necessary. If concerned wear protective

goggles or glasses. Wash hands after handling and prior to touching eye

and in particular handling contact lenses.

Skin

Skin protection is not normally necessary, however it is good practice to

avoid contact with chemicals by wearing suitable gloves when handling.

Respiratory

Protection from inhalation is not normally necessary. If ventilation is

inadequate or dust is likely to build up then use of a suitable dust mask

would be appropriate.

Appearance

White lotion

Odour

Non specific odour.

Vapour pressure

No data available.

Boiling point/range

No data available.

Freezing/Melting point

No data available.

Solubility

Miscible.

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MSDS|Antibiotic Lotion with Hydrocortisone and Lignocaine

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/7/Antibiotic+Lotion+with+Hydrocortisone+and+Lignocaine/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION V Fire Fighting Measures

SECTION VI Accidental Release Measures

SECTION VII Handling and Storage

SECTION VIII Exposure Controls and Personal Protection

SECTION IX Physical and Chemical Properties

Specific gravity/density

0.98g/mL.

Flash Points

No data available.

Flammable limits (in air)

No data available.

Ignition temperature

No data available.

Chemical stability

This mixture is stable under normal ambient and anticipated storage and

handling conditions of temperature and pressure.

Conditions to avoid

No specific conditions to avoid other than extreme heat.

Incompatible materials

No data available.

Decomposition products

May emit toxic fumes under fire conditions.

Hazardous reactions

No data available.

Handling of the formulated product is not expected to cause any adverse affects. The following data pertains

particularly to the active and any hazardous ingredients in the formulation, rather than this specific formulation.

Acute Health Effects

Ingestion

Eye contact is not a great risk as this product is a tablet. The data

available suggests that this product may cause a transient irritation that is

unlikely to be anything more than mildly uncomfortable. This effect should

disappear when the product is removed.

Skin

The data available suggests that skin contact is not harmful. Allergic

reactions may occur in sensitive individuals.

Inhalation

Inhalation is not a great risk for this product which is a lotion.

Chronic Health Effects

Ingestion

The data available suggests that repeated or prolonged ingestion of

neomycin may lead to malabsorption syndrome and diarrhoea. Repeated

or prolonged ingestion of hydrocortisone may lead to suppression of the

adrenal gland and iatrogenic hyperadrenocorticism.

There is no data available on the long term effects of eye contamination

with this product.

Skin

The data available suggests that sensitisation may occur and repeated or

prolonged skin contact may inhibit healing of lacerations or other injuries

due to the presence of hydrocortisone.

Inhalation

There is no data available on the long term effects of inhalation of this

product.

Advice to Doctor

Treatment for any adverse effects should be symptomatic.

Carcinogenicity

No ingredient in this formulation is known to be carcinogenic.

Compounding effects

Hydrocortisone is readily absorbed through the skin.

Ecotoxicity

No data available.

Persistence and Degradability

No data available.

Mobility

No data available.

3 of 4

MSDS|Antibiotic Lotion with Hydrocortisone and Lignocaine

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/7/Antibiotic+Lotion+with+Hydrocortisone+and+Lignocaine/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION IX Physical and Chemical Properties

SECTION XI Toxicological Information

SECTION XII Ecological Information

SECTION XIIIDisposal Considerations

Disposal Methods

Empty containers may be recycled or sent to a commercial waste disposal

site. Unused product should be suitable for landfill however contact the

relevant local Waste Disposal Authority.

Special Precautions

Do not dispose into sewers or waterways.

UN Number

None allocated.

UN Shipping Name

None allocated.

ADG Class

None allocated

Packing Group

None allocated.

Special Precautions

None allocated.

Hazchem Code

None allocated

Poisons Schedule

Not Scheduled

Date

This MSDS has been reviewed and updated as required in May 2009.

NOHSC: National Occupational Health and Safety Commission

ADG Class: Australian Dangerous Goods Class

CAS Number: Chemical Abstracts Service Number

TWA: Time Weighted Average

STEL: Short Term Exposure Limit

UN: United Nations

Disclaimer

This Material Safety Data Sheet has been developed according to WORKSAFE Australia, NOHSC Guidelines.

Hazard Classifications have been determined in consultation with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)].

However, to the best of our knowledge, the finished product is unlikely to cause harm to humans handling, administering and dispensing as per label

instructions.

The data, information and recommendations herein are represented in good faith and are believed to be correct as of the date hereof.

The purpose of this Material Safety Data Sheet is to describe products in terms of their safety requirements.

Apex Laboratories Pty Ltd make no representation of merchantability, fitness for a particular purpose or application, or of any other nature with respect to the

information or the product to which the information refers ("the product").

The information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability prior to use of the product.

The physical data shown herein are typical values based on material tested. These values should not be construed as guaranteed analysis of any specific lot

or as guaranteed specification for the product or specific lots hereof.

Due care should be taken to make sure that the use or disposal of this product and/or its packaging is in compliance with relevant Federal, State and Local

Government Regulations.

4 of 4

MSDS|Antibiotic Lotion with Hydrocortisone and Lignocaine

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/7/Antibiotic+Lotion+with+Hydrocortisone+and+Lignocaine/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION XIV Transport Information

SECTION XV Regulatory Information

SECTION XVI Other Information

Key to Abbreviations

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