The following Structured Product Label (SPL) was submitted to the FDA by Oceanside Pharmaceuticals for the product Fluorescein Sodium And Benoxinate Hydrochloride (NDC 68682-732). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 2 dosage and administration, 3 dosage forms and strengths, 4 contraindications, 5.1 corneal toxicity, 5.2 corneal injury due to insensitivity, 6 adverse reactions, 8.1 pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Instill 1 to 2 drops topically in the eye as needed.
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%).
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product.
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.
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.
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.
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.
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%.
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.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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 (Image 01)
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 (Image 02)
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:
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.
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.
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.
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.
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
NDC 68682-732-05
Rx Only
Fluorescein
Sodium and
Benoxinate
Hydrochloride
Ophthalmic
Solution,
0.3%/0/4% (STERILE)
5 mL
OCEANSIDE
PHAMACEUTICALS
Carton (Image 03)
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