Clinical Information
Gen. Code and Des.
48624 proparacaine/fluorescein sod OPHTHALMIC DROPS 0.5%-0.25%
Strength
0.5 %-0.25 %
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
52160000 LOCAL ANESTHETICS (EENT)
36580000 OCULAR DISORDERS
Active Ingredients
1360 proparacaine HCl 5875069
2214 fluorescein sodium 518478
Inactive Ingredients
3203 paraben 99967
FLUCAINE - fluorescein sodium and proparacaine hydrochloride solution/ drops
OCuSOFT, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
DESCRIPTION:
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:
fluform1
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:
fluform2
(click image for full-size original)
EACH mL CONTAINS: ACTIVES: Fluorescein Sodium, USP, 0.25% [2.5 mg]. Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES: Povidone, Boric Acid, Waer for Injection, Sodium
PRESERVATIVE: Methylparaben 0.1%.
CLINICAL PHARMACOLOGY
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 an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.
