Hello this is an article regarding Benzyl alcohol and its side effects in young children. Higher incidences of CAD may have forced FDA to relook in BA use.

www.annmariegianni.com/ingredient-watch-list-benzyl-alcohol-another-i

may be this may be the reason

www.annmariegianni.com/ingredient-watch-list-benzyl-alcohol-another-i

Benzyl alcohol is only a mild acute toxin with an LD50 of 1.2 g/kg in rats.[10] It oxidizes rapidly in healthy individuals to benzoic acid, conjugated with glycine in the liver, and excreted as hippuric acid. Very high concentrations can result in toxic effects including respiratory failure, vasodilation, hypotension, convulsions, and paralysis.

Benzyl alcohol is toxic to neonates, it is associated with the gasping syndrome.[11][12]

Benzyl alcohol has been reported to cause skin allergy.[13]

Benzyl alcohol is severely toxic and highly irritating to the eye.[10] Pure benzyl alcohol produces corneal necrosis.[14]

Benzyl alcohol is not considered to be a carcinogen and no data are available regarding teratogenic or reproductive effects.[10](FROM WIKIPEDIA)

This is Maria Isabel Ager. NO ANSWER !!  

No question !!! …. MIA

would be helpful to know what a 'PK' is....?

Thanks Satyaprasad and Raksha for your useful comments, ref, links, etc.  The deaths in neonates with IV is extremely useful for pediatricians and those dealing with neonates, that are premature, or have other problems or they wouldn't have an IV at all.  Very informative!

This is quite different than children with enough hair to have head lice.  Also the eyes should be covered with a wash cloth during treatment to avoid any product getting into the eyes, regardless of Treatment.

The Pharmacokinetic (PK) study is usually done early on in subjects with the disease  and a baseline blood draw is done prior to Rx and multiple time periods after treatment... over 30  min-24 hours depending on the drug  to determine absorption, by products, etc.   If there is absorption or other problems it will not go forward to additional studies.  This is safety data!  A treatment might be very effective ,but if it isn't safe it will not proceed to further FDA studies.  In this case 6 mths,was used for 5%BA (Ulesfia) because that was the age requested for FDA approval, where other products currently were 2, 4 or 6 yrs.in the case of OVIDE (0.5% malathion with 78% isopropanol, dipentene and turpeniol as "inactive ingredients").  Natroba (Spinosad ) has 10% BA as "inactive ingredients" and the pyrethrin/PBO products that were EPA approved over 65 yrs ago have BA as inactive, but were "grandfathered in " when NIX was FDA approved (1986).   I just bought some OTC pyrethrin/PBO lice treatment today to do another

"Comparative Efficacy of Pediculicides" study,, I've published 3 , it's time for an Update".  If 5%BA was the inactive ingredient, and the active micro encapsulated mineral oil, it could just be OTC.

Thanks! Terri