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Newborns (especially preterm) lack the ability to metabolize benzyl alcohol, leading to metabolic acidosis, respiratory distress, hypotension and (in reported cases) the often-fatal gasping syndrome. For this reason, only preservative-free sterile water (no benzyl alcohol) is used in pediatric or neonatal care
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GRAS simply means the FDA agrees that the substance, at intended use levels as a food additive or supplement, is safe based on common use history or expert opinion and does not pose acute toxicity concerns
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