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Fluorescein Sodium and Benoxinate Hydrochloride

FDA Drug Profile — Fluorescein Sodium and Benoxinate Hydrochloride, ALTAFLUOR

Drug Details

Generic Name
Fluorescein Sodium and Benoxinate Hydrochloride
Brand Names
Fluorescein Sodium and Benoxinate Hydrochloride, ALTAFLUOR
Application Number
NDA211039
Sponsor
Bausch & Lomb Americas Inc.
NDC Codes
3
Dosage Forms
SOLUTION/ DROPS, SOLUTION
Routes
OPHTHALMIC
Active Ingredients
BENOXINATE HYDROCHLORIDE, FLUORESCEIN SODIUM

Indications and Usage

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 )