Benoxinate

Mechanism-of-action class: Sodium Channel Interactions.

• Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic.

• Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product.contraindicated

Instill 1 to 2 drops topically in the eye as needed. Instill 1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 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. ( Error! Hyperlink reference not valid. ) 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 and may manifest as epithelial defects which may progress to permanent corneal damage with accompanying visual loss. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.

The following serious 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, 0.3%/0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions are 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 Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no available data on the use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% in pregnant women to inform any drug associated risk. Adequate animal reproduction studies have not been conducted with fluorescein sodium and/or benoxinate hydrochloride. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% 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 Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, 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 Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%, and any potential adverse effects on the breastfed infant from Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%. 8.4 Pediatric Use The safety and effectiveness of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% have been established for pediatric patients.

• Dec 14, 2017NDANDA208582Altaire Pharms Inc
• Mar 9, 2020NDANDA211039Bausch Lomb Ireland

1. 1Confusional State222%
2. 2Eye Pain222%
3. 3Headache222%
4. 4Nausea222%
5. 5Rash222%
6. 6Syncope222%
7. 7Abdominal Pain Upper111%
8. 8Abnormal Sensation In Eye111%
9. 9Blood Glucose Decreased111%
10. 10Device Calibration Failure111%
11. 11Disorientation111%
12. 12Dizziness111%
13. 13Documented Hypersensitivity To Administered Product111%
14. 14Dry Eye111%
15. 15Dysarthria111%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Benoxinate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
  Recruiting · Interventional · 112 enrolled · The University of Hong Kong
  NCT06220474updated 2026-04-27
• Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
  Completed · Phase 3 · Interventional · 74 enrolled · Sintetica SA
  NCT05926258updated 2026-03-09
• Identification of Cellular Biomarkers of Rare Eye Diseases in Adults
  Not yet recruiting · Interventional · 110 enrolled · Institut National de la Santé Et de la Recherche Médicale, France
  NCT07063719updated 2025-12-05
• Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness
  Completed · Phase 3 · Interventional · 20 enrolled · Medical University of Vienna
  NCT07230548updated 2025-11-17
• Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers
  Recruiting · Phase 1 · Interventional · 24 enrolled · Valenta Pharm JSC
  NCT06857890updated 2025-07-10
• Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges
  Recruiting · Phase 2 · Interventional · 300 enrolled · Valenta Pharm JSC
  NCT06843018updated 2025-07-10
• The Role of Adjuvant Corneal Crosslinking in the Management of Infective Keratitis
  Completed · Early phase 1 · Interventional · 40 enrolled · Research Institute of Ophthalmology, Egypt
  NCT06967376updated 2025-05-13
• Change in Ocular Perfusion After Intravitreal Anti-VEGF in Patients with Age-related Maculopathy or Diabetic Macula Edema
  Completed · Observational · 36 enrolled · Augenabteilung Allgemeines Krankenhaus Linz
  NCT06878573updated 2025-03-17
• Effectiveness of Intravitreal Injection of Aflibercept 8 mg in Resistant Diabetic Macular Edema, Retinal Vein Occlusion and Myopic Choroidal Neovascularisation Patients
  Not yet recruiting · Early phase 1 · Interventional · 60 enrolled · Tanta University
  NCT06879301updated 2025-03-17
• Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
  Completed · Phase 4 · Interventional · 68 enrolled · Alexandria University
  NCT05666362updated 2025-02-05

Frequently asked questions

How does Benoxinate work?

Mechanism-of-action class: Sodium Channel Interactions.

What is Benoxinate used for?

According to FDA labeling, Benoxinate carries indications including: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Benoxinate?

Benoxinate is classified as Anesthetics for topical use, Local anesthetics, Sodium Channel Interactions, Decreased Sensory-Somatic Nervous System Organized Electrical Activity.

What are the brand names for Benoxinate?

Benoxinate is marketed under brand names including Altafluor.

What are the contraindications for Benoxinate?

Benoxinate labeling lists contraindications including: Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product.. Always consult the full prescribing information and a clinician.