“If the document type is 34390-5 (Human OTC drug label) and the citation is not part352 (sunscreens), then there must be the following sections: 55106-9 (OTC- active ingredient section), 55105-1 (OTC - Purpose section), 50565-1 (OTC - keep out of reach of children section), 34067-9 (Indications & usage section), 34071-1 (Warnings section), 34068-7 (Dosage & administration section), and 51727-6 (Inactive ingredient section).”
This error generates when you are missing one of those sections, simply apply the correct LOINC (if the section is present) or add the section to your content of labeling to correct the error. If the section is not located in your content of labeling, you may have to revise it to stay in compliance.
In version 4.1, the SPL Portal automatically validates the Content Editor to ensure OTC products have the required sections above.
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