Table 2. Eardrops that are approved in Germany for the topical treatment of otitis externa.

Substance class	Active agent or combination of active agents	Approval	Dosage	Use in patients with eardrum perforation (according to manufacturer’s information*1)	Requires prescription?
Antibiotic eardrops	Ciprofloxacin 2 mg/mL	Depending on preparation, from age 1 year or 2 years	Depending on preparation, 0.25 mL bid for 7 days or 0.5 mL bid for 7 days	Depending on preparation*2 no (restricted application) or yes	Yes
	Ciprofloxacin 3 mg/mL	From age 1 year	3 drops bid (children) 4 drops bid (adults)	Yes	Yes
	7500 IU polymyxin B sulfate/mL 3500 IU neomycin sulfate/mL 0.02 mg gramicidin/mL	No information	2–3 drops 3–5×/d for 5–7 days	No	Yes
Antibiotic and steroid eardrops	3 mg ciprofloxacin/mL 1 mg dexamethasone/mL	From age 1 year	4 drops bid for 7 days	Yes	Yes
	3 mg ciprofloxacin/mL 0.25 mg fluocinolone acetonide/mL	From age 6 months	6–8 drops bid for 7 days	Yes	Yes
Steroid eardrops	Fluocinolone acetonide 0.25 mg/mL	From age 18 years	0.4 mL bid for 7 days	No	Yes
Steroid andanalgesic eardrops	Dexamethasone 0.224 mg/mL Cinchocaine 5.08 mg/mL Butane-1,3-diol 539.728 mg/mL	No information	2–4 drops tid-qid for a maximum of 10 days	In case of perforated eardrum, treatment for a short time under an otologist’s supervision	Yes
Analgesic eardrops	Phenazone 50 mg Procaine HCl 10 mg	From age 3 years; in younger children only under a physician’s supervision	Age 0–2 years: only under a physician’s supervision Age 3–14 years: 2–3 drops tid-qid from age 15 years: 5 drops tid-qid	No	No

*¹ Red list. The information provided here is taken from the information provided by the manufacturers.

*² For one preparation containing ciprofloxacin 2 mg/mL, there is a restricted application in case of eardrum perforation, even though other preparations conaining ciprofloxacin in the same dose or a higher dose are permitted in case of eardrum perforation.