US Softgel Label Artwork: OEM/ODM Review Before Printing

Create a verified content sheet before a design file

Start the label project with a content sheet that identifies the product, formula revision, shell ingredients, serving information, capsule count, responsible business details, and any proposed statements. Assign a source and reviewer to each field. The designer should receive approved content rather than be expected to reconstruct the formula from sales notes or copy another brand's label.

FDA's general labeling guide identifies core items including product identity, net quantity, nutrition labeling, ingredient information, and business identification. Use that framework to organize the content sheet. A complete review also needs to consider the actual product and current requirements, rather than treating this project checklist as a ready-to-print legal template.

Connect the Supplement Facts panel to the actual formula

FDA provides specific nutrition-labeling guidance for the Supplement Facts panel. Serving size, amounts, and applicable Daily Value information need to be reviewed using the appropriate current requirements and product data. Do not calculate the panel by taking the total softgel weight and treating all of it as the dietary ingredient amount.

Keep the fill, shell, and other ingredients visible in the review packet so the correct information can be placed in the correct location. Reconcile the panel, ingredient statement, directions, and capsule count as one set. If any field changes, identify every connected field that needs another check. Do not copy numerical Daily Values or example panels from an older guide without verifying the current rules.

Plan required information around the physical package

Get the actual label area, panel arrangement, bottle dimensions, and printer template before locking the layout. FDA distinguishes the principal display panel from other information areas and places product identity and net quantity on the principal display panel. The designer needs to know which surface the consumer will normally see and how the label wraps around it.

Review an actual-size proof on the intended bottle where feasible. Look at readable text, usable space, seam placement, and whether a curved surface hides important information. Reserve space for lot coding and any date statement the project will use. Requirements for format, prominence, and type size should be checked by the reviewer for that specific package.

Review claims and supporting statements before layout approval

Keep a separate list of proposed claims and other statements so the review is deliberate. It can include dietary statements, shell-source statements, sourcing descriptions, quality marks, and intended benefit language. Confirm the evidence and any permissions needed for each statement, and identify which language is still awaiting approval. The product name and graphics deserve review too.

A slogan added late by marketing can change the review even when the Supplement Facts panel remains untouched. Route all consumer-facing content through the agreed process before final artwork approval. Keep unsupported certification marks and regulatory-approval impressions out of the design. The manufacturing quotation should also clarify who reviews content and who is only providing artwork or printing services.

Release one print version and preserve its approval trail

Use a version identifier that connects the content sheet, artwork, printer proof, and final approval. Check both content and production details: dimensions, fonts, image resolution, colors, barcode readability where used, finishing instructions, and package-component identifiers. The printer can confirm print readiness, while the designated content reviewer confirms the approved wording; those are different decisions.

Before printing, resolve comments and record the reviewers and approval date. After printing, compare the received labels against the released version, and define what happens to superseded stock. If the capsule formula, serving information, or package count changes later, reopen the affected label fields. This workflow helps keep the commercial product, its records, and its printed presentation aligned.

Common questions