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.
- Standard shampoo production has a lower MOQ of 3,000 units with an 8-week lead time from PO confirmation.
- Anti-dandruff OTC shampoos require a higher MOQ of 5,000 units and 12 weeks lead time due to additional FDA-required testing and documentation.
- For OTC products, we conduct stability testing, efficacy validation, and complete dossiers for FDA registration.
- Packaging must include proper OTC labeling and child-resistant closures if required.
- Sampling takes 4-6 weeks for standard formulas but 6-8 weeks for OTC due to additional safety testing.
- We can support all documentation but cannot guarantee regulatory approval as that remains the brand’s responsibility.
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.