OTC products that pass the retailer's audit
An OTC topical is a drug, and retailers expect proof. InSpec Solutions manufactures external analgesics, sunscreen, and acne treatments with the batch records, Drug Facts support, and audit history buyers ask for before they place an order, so you don't have to worry about compliance becoming your problem.
In OTC, the documentation is part of the product
Ready for the FDA's audit, and the retailer's
When a brand scales an OTC product to retail, the manufacturer's compliance record becomes the brand's risk. Batch records, a clean FDA audit history, and accurate Drug Facts panels are what separate a manufacturer that can ship to Walmart from one that can't.
Every batch ships with a certificate of analysis and complete documentation, so when a retailer's quality team calls, there's a real answer.
Approved actives, approved concentrations, documented
We manufacture to the OTC monographs for external analgesics, sunscreen, acne, and skin protectants, so your actives, concentrations, and Drug Facts panel are right from the first batch. Tech transfer without reformulation is one of the most common reasons brands call us.
OTC actives we run
See pain-relief formulas →Move an OTC product without starting over
Brands bring OTC products to InSpec Solutions when they need more capacity, cleaner audit documentation, or a format their current line can't run. Where the spec allows, we take over monograph products without reformulation and bring the documentation up to what a national retailer expects.
Lidocaine, menthol, benzocaine, methyl salicylate, SPF, and acne actives, in creams, gels, roll-ons, and sprays.
Ready to manufacture your next OTC product?
Tell us your active, format, and target volume. We'll walk you through the manufacturing and compliance requirements, and a transition plan if you're adding capacity.