FLUCAINE by is a Prescription medication manufactured, distributed, or labeled by OCuSOFT, Inc.. Drug facts, warnings, and ingredients follow.
Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Fluorescein with the anesthetic action of Proparacaine Hydrochloride.
The active ingredient, Fluorescein Sodium, has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3' ,6' dihydroxy-,disodium salt. It is represented by the following structural formula:
The active ingredient, Proparacaine Hydrochloride, has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride. It is represented by the following structural formula:
This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur. Protection of the eye from irritating 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 anesthesia 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 sometimes, iritis with descementitis. 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.
Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes:
5 mL fill (glass bottle) / 5 mL fill (10 mL plastic bottle)
DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
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FLUCAINE
fluorescein sodium and proparacaine hydrochloride solution/ drops |
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Labeler - OCuSOFT, Inc. (174939207) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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OCuSOFT, Inc. | 174939207 | manufacture(54799-507) |
Mark Image Registration | Serial | Company Trademark Application Date |
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FLUCAINE 90051604 not registered Live/Pending |
OCuSOFT, Inc. 2020-07-14 |