Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.

Instill 1 to 2 drops of Altafluor Benox in the eye as needed.

Altafluor Benox is a yellow to orange-red ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%) and benoxinate hydrochloride 4 mg/mL (0.4%).

Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product.

The following 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 0.25% / 0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions were 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.

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use.

Fluorescein sodium is represented by the following structural formula:  

C20H10Na2O5                                                   Mol. Wt. 376.27

Chemical Name: Spiro [isobenzofuran-1 (3H),9’-9[9H] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt.

Benoxinate hydrochloride is represented by the following structural formula:

C17H28N2O3 • HCl                                                 Mol. Wt. 344.88

Chemical Name: 2-(Diethylamino) etyl 4-amino-3-butoxybenzoate monohydrochloride.

Each mL contains: Actives: fluorescein sodium 2.5 mg (0.25%) equivalent to fluorescein 2.2 mg (0.22%), benoxinate hydrochloride 4 mg (0.4%) equivalent to benoxinate 3.6 mg (0.36%); Inactives: povidone, hydrochloric acid, boric acid, sodium hydroxide, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.3 – 5.3). Preservative: chlorobutanol 11mg (1.1%).

This product is the combination of a disclosing agent with a rapidly acting ester anesthetic of short duration.

Controlled clinical studies in adults and pediatric patients have demonstrated that topical administration of fluorescein sodium and benoxinate hydrochloride ophthalmic solution 0.25%/0.4% enables visualization and corneal anesthesia sufficient to enable applanation tonometry, tear fluid dynamics evaluation and short conjunctival and corneal procedures. Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration.

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile, yellow to orange-red solution supplied in a 5 mL glass bottle with a sterilized dropper.

NDC #59390-218-05

Storage: Store in refrigerator at 2° to 8°C (36° to 46°F).  After opening, Altafluor Benox 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.

Accidental Injury Precaution

Advise patients not to touch their eyes for approximately 20 minutes after application. Their eyes will be insensitive due to the effect of the anesthetic, and care should be taken to avoid accidental injuries.

Rev. 12/2017                                   

Manufactured by:
ALTAIRE Pharmaceuticals, Inc.                                          
Aquebogue, NY 11931

NDC 59390-218-05
ALTAFLUOR
BENOX
Fluorescein Sodium and
Benoxinate Hydrochloride
Ophthalmic Solution, USP 
0.25%/0.4%
(Sterile)
5 mL
Rx Only