6.6.1. Ectoparasiticides for dogs and cats

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.

6.6.1.1. 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:

6.6.1.2. 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)

6.6.1.3. Label approval requirement 2

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

6.6.1.3.1. 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.
6.6.1.3.2. 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.
6.6.1.3.3. 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.

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General requirements: Ectoparasiticides for dogs and cats
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6.6. General directions