ALTAFLUOR- fluorescein sodium and benoxinate hydrochloride solution
Altaire Pharmaceuticals 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.
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4%
For Use in the Eyes Only
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic 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:
Mol. Wt.= 376.27
H Na O
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:
Mol. Wt.= 344.88
H N O · HCl
Chemical Name: 2-(Diethylamino) ethyl 4-amino-3butoxybenzoate monohydrochloride
EACH mL CONTAINS: ACTIVES: Fluorescein Sodium 2.5 mg (0.25%), Benoxinate Hydrochloride
4 mg (0.4%); INACTIVES: Povidone, Boric Acid, Water for Injection. Hydrochloric Acid may be
added to adjust pH (4.3-5.3). PRESERVATIVE: Chlorobutanol 1%.
This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.
INDICATIONS AND USAGE:
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
Known hypersensitivity to any component of this product.
Not for Injection. Topical Use Only. 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 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 systems 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 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 descemetitis.
Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-
258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Pregnancy Category C.
Animal reproductive studies have not been conducted with Fluorescein Sodium and Benoxinate
Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%. It is also not known whether Fluorescein
Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity. Fluorescein Sodium and
Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be given to a pregnant woman
only if clearly needed.
Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic
Solution USP, 0.25%/0.4% is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
DOSAGE AND ADMINISTRATION:
Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 to 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: 5 mL.
Store in a refrigerator at 2°-8°C (36°-46°F), can be stored at room temperature for up to 1 month. Keep
FOR USE IN THE EYES ONLY.
DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.
KEEP OUT OF REACH OF CHILDREN
ALTAIRE PHARMACEUTICALS, INC.
Aquebogue, NY 11931 USA
PRINCIPAL DISPLAY PANEL
Fluorescein Sodium and
Ophthalmic Solution, USP
fluorescein sodium and benoxinate hydrochloride solution
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:59 39 0 -20 6
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
BENO XINATE HYDRO CHLO RIDE (UNII: 0 VE4U49 K15) (BENOXINATE -
UNII:AXQ0 JYM30 3)
4 mg in 1 mL
FLUO RESCEIN SO DIUM (UNII: 9 3X55PE38 X) (FLUORESCEIN - UNII:TPY0 9 G7XIR)
in 1 mL
Stre ng th
PO VIDO NES (UNII: FZ9 8 9 GH9 4E)
BO RIC ACID (UNII: R57ZHV8 5D4)
Altaire Pharmaceuticals Inc.
WATER (UNII: 0 59 QF0 KO0 R)
HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)
CHLO RO BUTANO L (UNII: HM4YQM8 WRC)
NDC:59 39 0 -20 6 -
5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n
Pro duc t
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
UNAPPROVED DRUG OTHER
0 6 /21/20 0 0
Altaire Pharmaceuticals Inc. (786790378)
Ad d re s s
Busine ss Ope rations
Altaire Pharmaceuticals, Inc.
78 6 79 0 378
MANUFACTURE(59 39 0 -20 6 )