ALTAFLUOR

6 ADVERSE REACTIONS 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. The most common ocular adverse events are: stinging, burning and conjunctival redness. ( 6 ) 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.

4 CONTRAINDICATIONS: Altafluor Benox is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )

11 DESCRIPTION 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: C 20 H 10 Na 2 O 5 Mol. Wt. 376.27 Chemical Name: Spiro [isobenzofuran-1 (3 H ),9’-9[9 H ] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt. Benoxinate hydrochloride is represented by the following structural formula: C 17 H 28 N 2 O 3 • 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%). 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. Benoxinate Hydrochloride is represented by the following structural formula:

2 DOSAGE AND ADMINISTRATION Instill 1 to 2 drops of Altafluor Benox in the eye as needed. Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 2 )

1 INDICATIONS AND USAGE 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. Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a combination disclosing agent and local ester anesthetic indicated for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic. ( 1 )

12. CLINICAL PHARMACOLOGY This product is the combination of a disclosing agent with a rapidly acting ester anesthetic of short duration. 12. 2 Pharmacodynamics Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration. The anesthetic effect may be extended by subsequent administration 10-20 minutes after the last administration.

12. 2 Pharmacodynamics Maximal corneal anesthesia usually occurs in about 5-45 seconds and lasts about 20 minutes after single administration. The anesthetic effect may be extended by subsequent administration 10-20 minutes after the last administration.

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3 DOSAGE FORMS AND STRENGTHS: 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%). Ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%) and benoxinate hydrochloride 4 mg/mL (0.4%). ( 3 )

ALTAFLUOR Fluorescein Sodium and Benoxinate Hydrochloride FLUORESCEIN SODIUM FLUORESCEIN BENOXINATE HYDROCHLORIDE BENOXINATE CHLOROBUTANOL POVIDONE HYDROCHLORIC ACID BORIC ACID SODIUM HYDROXIDE WATER

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of Altafluor Benox have not been conducted.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of Altafluor Benox have not been conducted.

NDA208582

ALTAFLUOR

Fluorescein Sodium and Benoxinate Hydrochloride

59390-218

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

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

17 PATIENT COUNSELING INFORMATION 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

14 CLINICAL STUDIES 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.

8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

8.4 Pediatric Use The safety and effectiveness of Altafluor Benox have been established for pediatric patients. Use of Altafluor Benox is supported in pediatric patients by evidence from adequate and well controlled studies.

8.1 Pregnancy Risk Summary There are no available data on the use of Altafluor Benox in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Altafluor Benox should be given to a pregnant woman only if clearly needed.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on the use of Altafluor Benox in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Altafluor Benox should be given to a pregnant woman only if clearly needed. 8.2 Lactation Risk Summary There are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration of Altafluor Benox, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Altafluor Benox and any potential adverse effects on the breastfed infant from Altafluor Benox. 8.4 Pediatric Use The safety and effectiveness of Altafluor Benox have been established for pediatric patients. Use of Altafluor Benox is supported in pediatric patients by evidence from adequate and well controlled studies. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

16 HOW SUPPLIED/STORAGE AND HANDLING 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.