FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops

Fluorescein Sodium and Benoxinate Hydrochloride by

Drug Labeling and Warnings

Fluorescein Sodium and Benoxinate Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Oceanside Pharmaceuticals, Alliance Medical Products, Inc. (dba Siegfried Irvine). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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:

    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

    Risk Summary

    There are no available data on the use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% in pregnant women to inform any drug associated risk.

    Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% should be given to a pregnant woman only if clearly needed.

    8.2 Lactation

    Risk Summary

    There are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, the effects on the breastfed infant, or the effects on milk production.

    The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, and any potential adverse effects on the breastfed infant from Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%.

    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:

    chem

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

    Benoxinate hydrochloride is represented by the following structural formula:

    chem2

    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: 68682-732-05

    Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. After opening, 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.

    Distributed by:
    Oceanside Pharmaceuticals, a division of
    Bausch Health US, LLC
    Bridgewater, NJ 08807 USA

    Manufactured by:
    Siegfried-Irvine,
    9342 Jeronimo Road,
    Irvine, CA 92618 USA

    © 2020 Bausch Health Companies Inc. or its affiliates

    9677800

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 68682-732-05

    Rx Only

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

    5 mL

    OCEANSIDE

    PHAMACEUTICALS

    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: 68682-732
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68682-732-051 in 1 CARTON03/25/2021
    15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA21103903/25/2021
    Labeler - Oceanside Pharmaceuticals (832011691)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Medical Products, Inc. (dba Siegfried Irvine)102688657MANUFACTURE(68682-732) , PACK(68682-732) , LABEL(68682-732)
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