Fluorescein Sodium and Benoxinate Hydrochloride
These highlights do not include all the information needed to use FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4% safely and effectively. See full prescribing information for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4%. FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4%, for topical ophthalmic use Initial U.S. Approval: 2017
1797c5ef-66c4-4cf8-b62d-b484242be2ee
HUMAN PRESCRIPTION DRUG LABEL
Aug 31, 2022
Bausch & Lomb Incorporated
DUNS: 196603781
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluorescein Sodium and Benoxinate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC24208-734-05
Fluorescein Sodium
and Benoxinate
Hydrochloride
Ophthalmic Solution
0.3%/0.4%
(Sterile)
FOR TOPICAL OPHTHALMIC USE
[Eye Image]
Rx only****5 mL
BAUSCH + LOMB
9785301
CONTRAINDICATIONS SECTION
4 CONTRAINDICATIONS
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product.
Known hypersensitivity to any component of this product. ( 4)
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a yellow to orange-red ophthalmic solution containing fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%).
Ophthalmic solution containing fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%). ( 3)