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FDA Warns Public Against Unregistered Topical Products

The Food and Drug Administration (FDA) has issued an advisory warning the healthcare professionals and the public against the purchase or consumption of topical products that are not FDA-registered.

As per FDA Advisory no. 2021-2636-A, below is the list of unregistered topical products manufactured by Ellestreque Pharmaceutical and Industrial Corporation:

  • Methyl Salicylate Camphor + Menthol (Electruscent Oil) 25 mL
  • Aceite de Manzanilla 50 mL
  • Methyl Salicylate Oil of Wintergreen
  • EPHIC Aceite De Alcamforado 25 mL

The reason for this warning by the FDA is that the said products have not undergone the proper registration process with the FDA and there is no recognized or proper authorization in the form of a Certificate of Product registration.

The Food and Drug Administration Act of 2009 or Republic Act No. 9711 states that the manufacture, importation, sale, offering for sale, transfer, distribution, exportation, promotion, advertising, or sponsorship of health products without the proper authorization from the FDA is PROHIBITED.

SOURCE: FDA-Advisory-No.2021-2636-A

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