FDA warns public vs cooling gel patch for kids

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against the purchase and use of a cooling gel patch for kids with fever.

In an advisory, the FDA said the medical device product “Fever Aid for Kids” has not been issued a corresponding product notification certificate.

The gel patch is placed on the child’s forehead to bring down the body’s temperature when sick or with fever.

Pursuant to Republic Act 9711 or the Food and Drug Administration Act of 2009, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

“Since this unnotified medical device product has not gone through the evaluation process of the FDA, the agency cannot assure its quality and safety,” the FDA said.

“All concerned establishments are warned not to distribute, advertise or sell the said violative medical device product until product notification certificate is issued; otherwise, regulatory actions and sanctions shall be strictly pursued,” the advisory signed by FDA Director General Samuel Zacate stated.

The FDA also requested all law enforcement agencies and local government units to ensure that this product is not sold or made available in the market or in their areas of jurisdiction.

The agency also urged the Bureau of Customs to restrain the entry of this unnotified product.