Label: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 24208-734-05
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 19, 2020

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    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

    INDICATIONS AND USAGE

    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)

    DOSAGE AND ADMINISTRATION

    Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. (2)

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution containing fluorescein sodium 2.6 mg/mL (0.3%) and benoxinate hydrochloride 4.4 mg/mL (0.4%). (3)

    CONTRAINDICATIONS

    Known hypersensitivity to any component of this product. (4)

    WARNINGS AND PRECAUTIONS

    Corneal Toxicity: Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. (5.1)
    Corneal Injury: Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. (5.2)

    ADVERSE REACTIONS

    The most common ocular adverse events are: stinging, burning and conjunctival redness. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb, a Division of Valeant Pharmaceuticals North America LLC, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 3/2020

  • Table of Contents
  • 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.

  • 2 DOSAGE AND ADMINISTRATION

    Instill 1 to 2 drops topically in the eye as needed.

  • 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%).

  • 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.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Corneal Toxicity

    Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage with accompanying visual loss.

    5.2 Corneal Injury due to Insensitivity

    Patients should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.

  • 6 ADVERSE REACTIONS

    The following serious ocular adverse reactions are described elsewhere in the labeling:

    Corneal Toxicity [see Warnings and Precautions (5.1)]
    Corneal Injury due to Insensitivity [see Warnings and Precautions (5.2)]

    The following adverse reactions have been identified following use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.2 Lactation

    8.4 Pediatric Use

    The safety and effectiveness of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% have been established for pediatric patients. Use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is supported in pediatric patients by evidence from adequate and well controlled studies.

    8.5 Geriatric Use

    No overall differences in safety or effectiveness have been observed between elderly and younger patients.

  • 11 DESCRIPTION

    Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a sterile solution containing a disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use.

    Fluorescein sodium is represented by the following structural formula:

    chemstructure1
     
    C20H10Na2O5 Mol. Wt. 376.3

    Chemical Name: 3’,6’ Dihydroxy-3H-spiro[isobenzofuran-1,9-xanthen]-3-one disodium salt.

    Benoxinate hydrochloride is represented by the following structural formula:

    chemstructure2
     
    C17H28N2O3 • HCl Mol. Wt. 344.88

    Chemical Name: 2-(Diethylamino) ethyl 4-amino-3-butoxybenzoate hydrochloride.

    Each mL of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution 0.3%/0.4% contains:

    Active ingredients: fluorescein sodium 2.6 mg (0.3%) equivalent to fluorescein 2.3 mg (0.2%), benoxinate hydrochloride 4.4 mg (0.4%) equivalent to benoxinate 3.9 mg (0.4%)
    Preservative: chlorobutanol 12.6 mg (1.3%)
    Inactive ingredients: povidone, hydrochloric acid, boric acid, water for injection. Hydrochloric acid may be added to adjust pH (4.3 – 5.3)
  • 12 CLINICAL PHARMACOLOGY

    12.2 Pharmacodynamics

    Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration. The anesthetic effect may be extended by subsequent administration 10-20 minutes after the last administration.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies to evaluate the mutagenic or carcinogenic potential of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% have not been conducted. Studies to evaluate impairment of fertility have not been conducted.

  • 14 CLINICAL STUDIES

    Controlled clinical studies in adults and pediatric patients have demonstrated that topical administration of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% enables visualization and corneal anesthesia sufficient to enable applanation tonometry, tear fluid dynamics evaluation and short conjunctival and corneal procedures. Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is supplied as a sterile, aqueous, topical ophthalmic solution with a fill volume of 5 mL in a 6 mL amber glass bottle and a black polypropylene cap with a sterilized rubber dropper bulb and glass pipette.

    NDC 24208-734-05

    Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. After opening, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions. Keep tightly closed.

  • 17 PATIENT COUNSELING INFORMATION

    Accidental Injury Precaution

    Advise patients not to touch their eyes for approximately 20 minutes after application. Their eyes will be insensitive due to the effect of the anesthetic, and care should be taken to avoid accidental injuries.

    Manufactured for and Distributed by:

    Paragon BioTeck, Inc.

    4640 SW Macadam Ave, Ste 80

    Portland, OR 97239

    Manufactured by:

    Siegfried-Irvine,

    9342 Jeronimo Road,

    Irvine, CA 92618

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 24208-734-05

    Paragon
    BioTeck, Inc.

    Fluorescein
    Sodium and
    Benoxinate
    Hydrochloride
    Ophthalmic
    Solution,
    0.3%/0/4%

    Rx Only

    5 mL

    carton
  • INGREDIENTS AND APPEARANCE
    FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE 
    fluorescein sodium and benoxinate hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24208-734
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM2.6 mg  in 1 mL
    BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303) BENOXINATE HYDROCHLORIDE4.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-734-051 in 1 CARTON03/20/2020
    15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21103903/20/2020
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Medical Products, Inc. (dba Siegfried Irvine)102688657MANUFACTURE(24208-734)