FDABridge
← Back to blog
General

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics: Guide for Nigeria Exporters

Drug manufacturers in Lagos, Abuja must comply with FDA regulations before exporting to the United States. This article explains the key requirements — covering hand sanitizers, OTC drug, ethanol, antiseptic monograph, Drug Facts.

FDABridge TeamJan 1, 20262 min read

Drug manufacturers in Nigeria, particularly in Lagos, Abuja, are increasingly targeting the US market. With key products such as sesame seeds, cocoa, cashew nuts, Nigeria has significant potential in the American market. However, to legally introduce products into the US, companies must strictly comply with US Food and Drug Administration (FDA) regulations. This article details the FDA requirements related to this topic for Nigeria businesses.

Why hand sanitizers are OTC drugs in the United States

FDA regulations in this area apply to all foreign manufacturing facilities that wish to market products in the US. For drug manufacturers in Lagos and Abuja, compliance is not only a legal requirement but also a prerequisite for maintaining business relationships with US import partners. If requirements are not met, shipments can be held at the port, denied entry, or even placed on the FDA import alert list.

Active ingredient requirements and Drug Facts labeling

To export drug to the US, Nigeria companies need to: register their facility with the FDA, obtain a DUNS number from Dun & Bradstreet, appoint a US Agent with a US address, and ensure product labels comply with FDA regulations. For products such as sesame seeds, cocoa, cashew nuts, additional requirements may apply depending on the specific product type. FDABridge helps Nigeria companies complete the entire process.

FDABridge supports Nigeria exporters

FDABridge specializes in helping drug companies in Nigeria complete FDA registration from start to finish. Our services include consulting, DUNS number registration, US Agent provision, FDA facility registration filing, and periodic renewal. Contact us today at fdabridge.com to get started.

Need help next?

Need help choosing a service?

Compare the main service options and choose the filing path that fits your product category.