Tec Laboratories intends to work with the US Food and Drug Administration (FDA) to address the issues raised in a warning letter related to StaphAseptic Methicillin Resistant Staphylococcus Aureus (MRSA) prevention claims.
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Reportedly, the FDA warned Tec Laboratories over its StaphAseptic First Aid Antiseptic/Pain Relieving Gel, which claims on the label to kill ‘over 99.9% of MRSA, staph and strep.’
The FDA has provided Tec Laboratories with 15 working days from 18 April to respond to the letter.
Tec Laboratories said it will take necessary steps to meet the agency’s primary concern for public health and safety.
StaphAseptic, which contains Lidocaine, is available in a 1 oz. or 2 oz. tube and single use packets.
It is applied to minor cuts, scrapes and abrasions to prevent skin infections.
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