Description of Event or Problem · 1
RPTR HAS SOME QUESTIONS ABOUT LABELING ON A PRODUCT WHICH IS A FIRST AID PRODUCT FOR BURN INJURIES. SINCE BURN INJURIES ARE A SERIOUS TYPE OF INJURY, RPTR THINKS THE LABELING COULD MISLEAD CONSUMERS AND CAREGIVERS. THE MFR IS IN AUSTRALIA. HOWEVER, THE OWNER OF THE 510K-K984082 RESIDES IN SOUTH AFRICA. THE DISTRIBUTION NOW SEEMS TO BE THROUGH A CO IN VIRGINIA, GENESIS MEDICAL, INT'L, ADDRESS: 6550 COMMONWEALTH DRIVE, ROANOKE, VIRGINIA 24018 540-776-1659. THE FOLLOWING ARE RPTR'S QUESTIONS: ON THEIR WEB PAGE: HTTP://WWW.BURN-AID.COM/INDEX.HTM, THEY STATE THAT THE PRODUCT IS NON-TOXIC AND NON-IRRITANT. RPTR HAS NOT BEEN ABLE TO LOCATE TESTING TO PROVE THIS. ON THE "PRODUCT LINE" SECTION OF THEIR WEB PAGE, THEY STATE ON THE PRODUCT PACKAGING SHOWN THAT THE PRODUCT IS "ANTISEPTIC - GUARDS AGAINST INFECTION." RPTR CAN'T FIND WHAT THE INGREDIENT IS THAT MAKES THE PRODUCT "ANTISEPTIC." ON THEIR "TECHNICAL INFORMATION" PAGE, THEY STATE THAT THE INGREDIENTS ARE WATER, GELLING AGENT, AND TEA TREE OIL EXTRACT. RPTR ASKS IF THEY ARE ABLE TO MAKE THE ANTISEPTIC CLAIM BASED ON THE TEA TREE OIL EXTRACT. RPTR HAS LITERATURE IN THEIR POSSESSION WHICH STATES THAT THEY HAVE "ALL NATURAL ACTIVE INGREDIENTS." RPTR ASKS IF THIS IS AN APPROPRIATE CLAIM. RPTR'S LAST QUESTION IS IN REGARDS TO SHELF LIFE. RPTR HAS PACKAGES WHICH SHOW AT LEAST A FIVE YEAR SHELF LIFE. RPTR ASKS IF THERE ARE ANY REQUIREMENTS THEY MUST MEET TO BE ABLE TO MAKE THIS CLAIM.