Dosage and administration
Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 or 2 drops (in single instillations) in each eye before operating.
Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 or 2 drops (in single instillations) in each eye before operating.
Store in a refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to one month. Keep tightly closed. DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING. KEEP OUT F REACH OF CHILDREN
Flourescein Sodium and Benoxinate Hydrochloride Opthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration.
Fluorescein Sodium is represented by the following structural formula:
Chemical Name: Spiro [isobenzofuran-1 (3H),9'-[9H] xanthene]-3-one, 3',6' dihydroxy, disodium salt.
Benoxinate Hydrochloride is represented by the following structural formula:
Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride.
ACTIVES: Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%)
INACTIVES: Povidone, Boric Acid, Water For Injection. Hydrochloric Acid may be added to adjust pH (4.3 - 5.3).
PRESERVATIVE: Methylparaben 0.1%
This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.
For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as
tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.
Known hypersensitivity to any component of this product.
Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal
opacification with accompanying visual loss. Avoid contamination - do not touch tip of sterile dropper
used to dispense solution to any surface. Replace container closure immediately after using.
This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or
hyperthyroidism. The long-term toxicity is unknow; prolonged use may possible delay woundhealing. Although
exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity
manifested by central nervous sytem stimulation followed by depression may occur. Protection of the eye from
irritation, chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked
in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should
be advised to avoid touching the eye until the anesthsia has worn off.
Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics,
as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse
epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments
and someimes, iritis with descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988
Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 or 2 drops (in single instillations)
in each eye before operating.
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied
in a glass bottle with a sterilized dropper in the following size: 5mL
Store in a refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to one month.
Keep tightly closed.
DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
KEEP OUT F REACH OF CHILDREN
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54799-508-05 | ML - Milliliter | 54799-508 | 9d9503b4-17ce-4c94-83b8-0d07d7e1175a | 1 | 2014-02-04 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benoxinate Hydrochloride | ACTIVE INGREDIENT | 0VE4U49K15 | 1 | |
| Fluorescein Sodium | ACTIVE INGREDIENT | 93X55PE38X | 1 | |
| Benoxinate | ACTIVE MOIETY | AXQ0JYM303 | 1 | |
| Fluorescein | ACTIVE MOIETY | TPY09G7XIR | 1 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54799-508 | 54799-508-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Fluorescein Sodium | 93X55PE38X | ACTIM |
| Benoxinate Hydrochloride | 0VE4U49K15 | ACTIB |
| Povidone, Unspecified | FZ989GH94E | IACT |
| Boric Acid | R57ZHV85D4 | IACT |
| Hydrochloric Acid | QTT17582CB | IACT |
| Water | 059QF0KO0R | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | CREAM / TOPICAL | 38 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRACAUDAL | ADJ PH | ||
| Boric Acid | BORIC ACID | R57ZHV85D4 | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.3 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | TABLET / ORAL | 2.32 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / ORAL | 100 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / NASAL | 91.7 mg/100ml | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRATHECAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRASYNOVIAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| Povidones | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | POWDER, FOR SUSPENSION / ORAL | 125 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAVENOUS | 18.25 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION / SUBMUCOSAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.7 %w/w | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / AURICULAR (OTIC) | 0.37 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | TABLET, EXTENDED RELEASE / ORAL | 24 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / RESPIRATORY (INHALATION) | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SHAMPOO / TOPICAL | 104 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVENOUS | 1037 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | GEL, METERED / TOPICAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 5 mg | ||
| Povidones | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | LOTION / TOPICAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRATHECAL | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVASCULAR | ADJ PH | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| Boric Acid | BORIC ACID | R57ZHV85D4 | MOUTHWASH / BUCCAL | 7.36 mg/1ml |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f70d5e3b-9437-42c8-babe-e8aac5bfc2c7 | 900ec4c1-e5e3-e940-5b02-cf2589955e20 | 2022-05-23 | Warnings, Adverse reactions | 900ec4c1-e5e3-e940-5b02-cf2589955e20 |
Adverse event summaries are temporarily unavailable. Other product information remains available.