Ectoparasiticides for dogs and cats

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

1. ‘Active constituent’ statement

The active isomer (and, where relevant, the isomeric ratio) must be specified. For example:

S-methoprene and permethrin 60:40

Active constituents of mixtures should be shown in a column, in descending order based on the concentration of each active constituent present. When synergists are also present, they should be shown after the main active constituent(s), even when they are present in the product at a higher concentration than the active constituents(s) (for example, piperonyl butoxide as a synergist for pyrethrin).

2. Product name

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

READY FOR USE

3. Indications

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 should 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.

Both the common and scientific name 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 75–95 per cent) must show the following statement:

This product is an aid 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.

4. ‘Net contents’ statement

Contents of aerosol cans must be expressed as:

[x] g NET

5. Directions for use

5.1. Contraindications

Either of the following contraindication statements should 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.

5.2. 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 dribbling and unsteady gait in cats. If these  occur, wipe off excess product and contact a veterinarian.

5.3. Dosage and administration

The directions for use should be simple, clear and concise and at least provide the minimum information necessary on how to use the product appropriately. Where appropriate, the dosage and administration instructions may appear in tabular form.

5.4. General directions

The following statement must appear in sans-serif, bold-face capital letters of not less than 2 mm in height:

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

Advice on control of fleas in the animal’s environment (zone control) is required (for example, treat bedding, carpet, etc).

5.5. 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. We will require this information by applying a special condition to the label approval for these products. Details of the conditions are explained below:

5.5.1. Warning image

5.5.1.1. Label approval condition 1

The label contains 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 (the ‘warning image’).

These diagrams demonstrate the two approaches available for presenting warning images regarding permethrin spot-ons for dogs and cats. The white keyline version of the diagram should measure 20 mm wide, 18 mm high. The white box version of the diagram should measure 22 mm wide and 18.5mm high. The text on both diagrams is 1.9 mm for the words ‘TOXIC’ and ‘USE’ and 1.5  for the words ‘TO CATS’ and ‘ON DOGS’. The diagram shows a black silhouette of a cat and a dog on a white background. Around the silhouette of the cat is a red frame that includes a cross at the top and the words ‘TOXIC TO CATS’ underneath in white text. Around the silhouette of the dog is a green frame that includes a tick at the top and the words ‘USE ON DOGS’ underneath in white text.

5.5.2. Warning text

5.5.2.1. Label approval condition 2

The label  contains the following text in the following form (the ‘warning text’):

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 sentence is to begin on a separate line.

5.5.2.2. Label approval condition 3

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

  • front of package:
    • the warning image is to be placed on the front of each package in the dimensions stated  in condition 1 or a larger dimension
    • the PMS colours are to be green PMS 355C and red PMS 485C
    • the warning image is to be placed beneath the active constituents, and as close to the active constituents as possible in accordance with the APVMA Labelling Code or Labelling Standard, whichever is in force at the time.
  • back of package:
    • the same version of the warning image that is used on the front of the package is to appear on the back of the package, beneath the ‘Directions for use’ heading
    • the warning image is to be in the dimensions stated above in condition 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 is to 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 condition 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 condition 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.

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