WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS Corneal toxicity: Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. (5.1) Corneal injury: Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. (5.2) Corneal toxicity: Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. (5.1) Corneal injury: Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. (5.2) 5.1 Corneal Toxicity. Prolonged use or abuse may lead to corneal epithelial toxicity which may manifest as epithelial defects and progress to permanent corneal opacification with accompanying visual loss.. 5.2 Corneal Injury Due to Insensitivity. Patient should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.

CONTRAINDICATIONS SECTION.

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).

ADVERSE REACTIONS SECTION.

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 population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.. Corneal Toxicity see Warnings and Precautions (5.1) . Corneal Injury due to Insensitivity see Warnings and Precautions (5.2) . 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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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

CLINICAL PHARMACOLOGY SECTION.

12. CLINICAL PHARMACOLOGY This product is the combination of disclosing agent with 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.

CLINICAL STUDIES SECTION.

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.

DESCRIPTION SECTION.

11 DESCRIPTION Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is sterile disclosing agent in combination with short-acting ester anesthetic for topical ophthalmic use.Fluorescein sodium is represented by the following structural formula: C20H10Na2O5 Mol. Wt. 376.27Chemical 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. 344.88Chemical 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 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 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:.

DOSAGE & ADMINISTRATION SECTION.

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

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS: Altafluor Benox is yellow to orange-red ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%) and benoxinate hydrochloride mg/mL (0.4%). Ophthalmic solution containing fluorescein sodium 2.5 mg/mL (0.25%) and benoxinate hydrochloride mg/mL (0.4%). (3).

GERIATRIC USE SECTION.

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

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is sterile, yellow to orange-red solution supplied in 5 mL glass bottle with sterilized dropper.NDC 59390-218-05Storage: Store in refrigerator at to 8C (36 to 46F). 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.

INDICATIONS & USAGE SECTION.

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

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION Accidental Injury PrecautionAdvise 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.

LACTATION SECTION.

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 mothers clinical need for Altafluor Benox and any potential adverse effects on the breastfed infant from Altafluor Benox.

NONCLINICAL TOXICOLOGY SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 59390-218-05ALTAFLUORBENOXFluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4%(Sterile)5 mLRx Only. NDC 59390-218-05ALTAFLUORBENOXFluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, USP 0.25%/0.4%(Sterile)5 mLRx Only.

PEDIATRIC USE SECTION.

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.

PHARMACODYNAMICS SECTION.

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.

PREGNANCY SECTION.

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 pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

5.1 Corneal Toxicity. Prolonged use or abuse may lead to corneal epithelial toxicity which may manifest as epithelial defects and progress to permanent corneal opacification with accompanying visual loss.

USE IN SPECIFIC POPULATIONS SECTION.

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 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 mothers 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.