Claims that Germstar antiseptic cleanser line treat swine flu, E-coli, salmonella and norovirus are not part of an OTC final monograph or TFM, FDA says in warning letter. The products contain active ingredients FDA deferred from OTC monographs for consumer and health care rubs to await additional data.
The active ingredients in Soaptronic LLC’s Germstar antiseptic hand cleanser line are allowed while their safety and efficacy are under review, but claims that the products treat swine flu, E-coli, salmonella and norovirus aren’t allowed, says the US Food and Drug Administration.
The products, which contain either isopropyl alcohol or ethyl alcohol and are provided for either consumer or health care facility...
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