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  • Writer's pictureDaniel Jiménez

Registration of OTC products in the US

The US is a very attractive market for the sale and export of cosmetic products. Big (and increasingly small) companies have aroused their interest in this market with more than 300M of potential consumers.

However, some products that in Europe are considered as a cosmetics are considered drugs in the US under the Federal Drug Administration (FDA) rules. Among these drugs, those with a low risk to the user health are considered OTC (Over the Counter Drugs) and can be sold without any prescription.

It is the case of sunscreens, antiperspirants, anti-dandruff products or mouthwashes, among others products.

Registering an OTC product in the USA under FDA compliance is a laborious process that requires the following steps:

At Belab Services we take care of the entire process efficiently and with maximum agility and professionalism to register your over-the-counter (OTC) products in the United States and act as a Authorized Representative with the FDA.

For more information, do not hesitate to contact us.

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