Drug Facts
Composition & Profile
Identifiers & Packaging
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, 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.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-734-05 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 carton
- 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, 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.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-734-05 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 carton
Overview
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: 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). ChemFluorescein ChemBenoxinate
Indications & 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. 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 & Administration
Instill 1 to 2 drops topically in the eye as needed. Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 2 )
Warnings & 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. ( Error! Hyperlink reference not valid. ) 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 ) 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.
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 )
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. The most common ocular adverse events are: stinging, burning and conjunctival redness. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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