Excipient | Age | Limit | Explanation |
Ethanol21 | <2 years | Avoid | |
2–5 years | 6 mg/kg | Suggested limit in medicines based on a BAC rise of 0.01 g/L. | |
≥6 years | 75 mg/kg | Suggested limit in medicines based on a BAC rise of 0.125 g/L. | |
Propylene glycol26 | Neonates | 1 mg/kg/day | Considered to be safe and with no noticeable effects whatever the duration and the route of administration.* |
1 month–4 years | 50 mg/kg/day | ||
≥5 years | 500 mg/kg/day | ||
Benzyl alcohol29 | Preterms and neonates | Not recommended | |
Propyl paraben30 | Any | 2 mg/kg/day | Permitted daily exposure according to the method outlined in ICH Q3C. |
*With the exception of inhalation.
BAC, blood alcohol concentration; EMA, European Medicines Agency; ICH Q3C, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C.