In addition to the standard labelling requirements, labels on ectoparasiticides for dogs and cats must also carry the following information, as applicable.

2. Product name

Where a product does not require further dilution before usage, the following words may be included in the product name:

READY TO USE

3. Constituent statements

3.1. 'Active constituent' statement

The active isomer (and, where relevant, the isomeric ratio) must be specified under the ‘Active constituent’ heading. For example:

S-methoprene and permethrin 60:40

4. Statement of claims for use

Where control of ticks is claimed, the species name of ticks must be stated. Where tick control is claimed and paralysis tick is not controlled, the following statement must appear:

Does not control paralysis tick (Ixodes holocyclus)

Products that claim to control Ixodes holocyclus should have the following label statement:

Ixodes holocyclus ticks do not occur in Western Australia

If a claim is made in relation to I. holocyclus ticks, the following grooming statement must appear:

In tick season, daily searching for, and removal of, any ticks found is recommended
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Both the common and scientific names of parasites must appear in the 'Claims' statement on the label. The scientific name must be written in italics or underlined. The scientific names are optional in the summary claim appearing on the main panel if they appear in the complete claim on the ancillary panel.

 

Products that have the claim ‘aids in the control of fleas’ (efficacy 75% to 95%) must show the following statement:

Aids in the control of fleas and may not completely eliminate fleas from treated animals. Total eradication of fleas requires appropriate treatment of both the animal and its environment. A veterinarian should be consulted when flea infestation continues to be a problem.

A repellent claim is not permitted in relation to ticks and fleas without supporting data.

6.2. Contraindications

Either of the following 'Contraindications' statements must appear on all products, except those containing pyrethrins or permethrin (unless data to the contrary is supplied):

Not recommended for use on kittens and puppies under 3 months of age
Must not be used on kittens and puppies under 3 months of age

6.4. Side effects

Sprays containing pyrethrin or permethrin and intended for use on cats must carry the following statement under the ‘Side effects’ heading:

May cause drooling and unsteady gait in cats. If these occur, wipe off excess product and contact a veterinarian.

Products containing actives belonging to the isoxazoline family must contain the following statement:

[Active(s)] is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lethargy, inappetence, itching and very rarely, seizures. Most adverse reactions are self-limiting and of short duration. If you have any concerns, please speak to your veterinarian.

6.6. General directions

The following statement must appear under the ‘General directions’ heading:

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.
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The general limitation statement must be printed in bold-face and sans-serif capital letters. For print size and style requirements, refer to the Printing and legibility requirements.

 

Advice on the control of fleas in the animal’s environment may be required (for example, treat bedding, carpet, etc.) as determined by the APVMA during product evaluation.

6.6.1. Dog spot-ons that contain permethrin

In addition to the standard labelling requirements and those described above, dog spot-ons that contain permethrin must also carry the following information.

The label must contain the following warning statements:

Keep cats separated from recently treated dogs.
There are reports of toxic effects in cats which groom or contact dogs treated 48 hours earlier.
Toxic effects include behaviour changes, drooling, tremors and death.
Seek veterinary advice immediately if you suspect toxicity in a cat.

Each warning statement is to begin on a separate line.

For the purpose of the E-label template these statements should be placed under the ‘General directions’ heading.

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The warning image and the warning statements are displayed on the label in accordance with the following requirements:

Label approval requirement 1 (warning image)

The label must contain either the white keyline image or the white box image set out below at greater than or equal to the dimensions specified for each image.

Label presentation - label approval requirement 1 (warning image)

Label approval requirement 2

The warning image and the warning text must be displayed on the label in accordance with the following requirements:

Front of package

  • The warning image must be placed on the front of each package in the dimensions stated in requirement 1 or a larger dimension.
  • The PMS colours must be green PMS 355C and red PMS 485C.
  • The warning image must be placed beneath the active constituents and as close to the active constituents as possible in accordance with the APVMA Labelling Code.

Back of package

  • The same version of the warning image used on the front of the package must appear on the back of the package, beneath the ‘Directions for use’ heading.
  • The warning image must be in the dimensions stated above in requirement 1 or a larger dimension.
  • The warning text must accompany the warning image and be either directly below or beside the warning image.
  • The warning text must be in at least the same size text as the rest of the text on the back of the package.

Internal packaging

  • For internal foil packs, the warning image must be in the dimensions stated in requirement 1 or a larger dimension, but may be printed in a single colour.
  • For pipettes, a version of the warning image is to appear if space permits. If space does not permit, the words ‘toxic to cats’ must appear in text at least 1.5 mm high.
  • For leaflets, the warning image must be in the dimensions stated above in requirement 1 or a larger dimension and may be printed in a single colour. The warning text must appear as it appears on the back of package.