Label: FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE solution/ drops
- NDC Code(s): 68682-732-05
- Packager: Oceanside Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated March 19, 2020
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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: 2017INDICATIONS 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
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- 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)
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- 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 Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2020
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Corneal Toxicity
5.2 Corneal Injury due to Insensitivity
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.2 Pharmacodynamics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
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6 ADVERSE REACTIONS
The following serious ocular adverse reactions are described elsewhere in the labeling:
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- Corneal Toxicity [see Warnings and Precautions (5.1)]
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- 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.
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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.
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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:
Chemical Name: 3’,6’ Dihydroxy-3H-spiro[isobenzofuran-1,9-xanthen]-3-one disodium salt.
Benoxinate hydrochloride is represented by the following structural formula:
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:
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- 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%)
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- Preservative: chlorobutanol 12.6 mg (1.3%)
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- 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
- 13 NONCLINICAL TOXICOLOGY
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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.
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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.
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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
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INGREDIENTS AND APPEARANCE
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
fluorescein sodium and benoxinate hydrochloride solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-732 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM 2.6 mg in 1 mL BENOXINATE HYDROCHLORIDE (UNII: 0VE4U49K15) (BENOXINATE - UNII:AXQ0JYM303) BENOXINATE HYDROCHLORIDE 4.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) BORIC ACID (UNII: R57ZHV85D4) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68682-732-05 1 in 1 CARTON 03/25/2021 1 5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA211039 03/25/2021 Labeler - Oceanside Pharmaceuticals (832011691) Establishment Name Address ID/FEI Business Operations Alliance Medical Products, Inc. (dba Siegfried Irvine) 102688657 MANUFACTURE(68682-732) , PACK(68682-732) , LABEL(68682-732)
