Table 2.

Tolerance limits for excipients ethanol, propylene glycol, and benzyl alcohol proposed by the European Medicines Agency (EMA) [15, 20, 48]

	Neonates	Infants/children
Ethanol	No limit proposed  At least similar to infants/children	6 mg/kg/day for “patients aged 2–6 years”
Propylene glycol	1 mg/kg/day	50 mg/kg/day for patients “aged 29 days to 4 years”
Benzyl alcohol	Contraindicated	5 mg/kg/day “for adults and children aged over 4 weeks”