The FDA changed the requirements for verbiage displayed on Oxygen USP cylinder labels. All cylinders must be compliant by December 18, 2025.
Labels currently on cylinders must be fully removed and replaced with a new label. It is not permitted to apply one label over top of another.
New requirements include:
Recommended Way to Replace Cylinder Labels
1. Ensure the cylinder is empty.
Always confirm the cylinder is completely empty before beginning work.
2. Use a plastic label scraper.
We recommend plastic scrapers because they are less likely to damage the clearcoat finish on cylinders than other types of scrapers.
3. Remove the label completely.
Begin scraping the label from the cylinder until it is fully removed.
4. Clean off adhesive residue.
Adhesive residue from the label or other stickers can be removed using an approved oxygen-compatible label remover.
5. Prepare the surface.
Once the label has been removed and the area is clean, prepare the surface for the new label.
6. Mark cylinder contents (if applicable).
If the new label has a section to mark the cylinder contents, we recommend using a hole punch to mark the contents box before applying the label.
7. Apply the new label.
Place the new label on the cylinder, ensuring there are no creases or fold-overs.
Labels Under the Clearcoat
If the cylinder has labels applied under the clearcoat finish, the process is different. Do not apply a new label over the old one. The clearcoat finish will need to be removed so the label can be taken off. This process should be performed by a hydro tester or another qualified expert.
Plan Ahead
With the compliance deadline approaching, now is a good time to review cylinder inventory, determine which labels will need to be replaced, and create a plan to meet the requirements by December 18, 2025.
We carry FDA-compliant oxygen cylinder labels and oxygen-compatible label removers to help meet these requirements.
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