(a) Specifications. The drug is an aqueous solution containing 0.5 percent proparacaine hydrochloride, 2.45 percent glycerin as a stabilizer, and 0.2percent chlorobutanol (choral derivative) and 1:10,000 benzalkonium chloride as preservatives.
CFR 21-524.1982-2014 history
2014CFR 21-524.1982-2014 Food and drugs. Part524:Ophthalmic and topical dosage form new animal drugs. Section524.1982:Proparacaine ophthalmic solution.