Guidance on veterinary drug labelling: Labelling unique types of packages

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This section outlines the requirements for labelling special packages, including labelling drugs in pressurized containers and flammability, drugs in small containers and drugs in co-packaging.

Drugs in pressurized containers and flammability

Drugs packaged in a disposable metal container that have a manually operated valve are designed to release pressurized contents. These should show the cautionary statements, hazard symbols and signal words as outlined in the Regulations.

Drugs packaged in unpressurized containers operated by a manual pump spray device or any other containers that contain flammable ingredients should have the proper hazard symbol. There should also be a cautionary warning indicating the contents are flammable. Appropriate directions for use (for example, "do not use near an open flame") must be provided.

Drugs in small containers

The labelling requirements for drugs apply to most container sizes.

Some containers are too small to carry all the information required. The inner label requirements do not apply to the drug in that container as long as:

You may contact us to discuss potential approaches in case 1 of the following scenarios applies:

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Co-packaged products

The 2 main scenarios of co-packaging for veterinary drugs are outlined below. If you have questions about co-packaging, contact us at

Co-packaging scenarios

For these scenarios, the product labelling (including package insert) must comply with the Regulations. When separate containers of distinct drug products are packaged together, each product must meet the labelling requirements and have approved labelling. This means:

If claims for the co-packaged products exceed the authorized claims for the components or new claims are made on their concomitant administration, you must file another drug submission.

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