Application Nr Approved Date Route Status External Links
NDA211039 None Ophthalmic None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluorescein Sodium And Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% Is Indicated For Ophthalmic Procedures In Adult And Pediatric Patients Requiring A Disclosing Agent In Combination With A Topical Ophthalmic Anesthetic Agent. Fluorescein Sodium And Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% Is A Combination Of Fluorescein Sodium, A Disclosing Agent And Benoxinate Hydrochloride, A Local Ester Anesthetic Indicated For Procedures In Adult And Pediatric Patients Requiring A Disclosing Agent In Combination With A Topical Ophthalmic Anesthetic. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Benoxinate Hydrochloride BENOXINATE HYDROCHLORIDE ZINC2019492
2. Fluorescein Sodium FLUORESCEIN SODIUM ZINC3872582

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