Quick Answer (for busy buyers)
Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.
- In the US, whether an eye-care product is a drug is driven mainly by intended use communicated by claims (label, A+ content, ads, Amazon bullets, reviews you amplify), not by the physical form.
- To give you compliant, practical guidance, please share your exact claim list and any active ingredients (including concentrations) and whether it is intended for use in the eye (intraocular) vs around the eye (external skin).
- As a working rule, claims that diagnose, treat, cure, mitigate, or prevent disease, or that affect the structure/function of the body (e.g., treat dry eye disease, relieve redness, allergy relief, antibiotic/antiviral, lowers IOP, treats infection, anti-inflammatory) typically trigger OTC drug requirements and Drug Facts labeling, plus appropriate testing and documentation.
- Softer cosmetic claims (comfort, refresh, moisturize around the eye area) may stay non-drug if they do not imply medical treatment.
- Operationally, we can support samples in ~10-15 days after formula brief, typical MOQ 3,000-10,000 units per SKU depending on packaging (sterile single-dose vials vs multi-dose bottle), and lead time ~30-45 days after artwork/PO.
- We can help with COA/SDS, micro limits/stability, packaging compatibility, and label content review support (not legal advice).
Buyer outcome
A launch-ready compliance plan: inputs collected, roles assigned, and update cadence defined.
Most common blocker
Missing facility information + inconsistent ingredient/label snapshots across SKUs.
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This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.