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Fixed-dose combination

Benoxinate and Fluorescein

Also known as benoxinate hydrochloride, fluorescein sodium
Available on requestCold chain
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Benoxinate and Fluorescein is a fixed-dose combination medicine indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. It is available as eye drops and ophthalmic solution. MedsAcross supplies Benoxinate and Fluorescein for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Diagnostic Dye, Dyes
US FDA first approval
14 December 2017
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops, Ophthalmic solution
Fixed-dose combination of
Benoxinate, Fluorescein

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

Dosing overview

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.

Source: US FDA prescribing information

Contraindications

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

Source: US FDA prescribing information

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. 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.

Source: US FDA prescribing information

Side effects

The following ocular adverse reactions are described elsewhere in the labeling: Corneal Toxicity Corneal Injury due to Insensitivity 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.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Benoxinate and Fluorescein, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Benoxinate and Fluorescein 4.4 mg/2.6 mg per mL eye dropsOphthalmic Cold chainGeneric nameBenoxinate and Fluorescein—US FDAAvailable on request
Altafluor 4 mg/2.5 mg per mL ophthalmic solutionOphthalmic Cold chainBenoxinate and FluoresceinAltaire PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Altafluor

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 December 2017Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Benoxinate and Fluorescein available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Benoxinate and Fluorescein and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Benoxinate and Fluorescein have?

The catalogue lists 1 brand names for Benoxinate and Fluorescein, including Altafluor.

Is Benoxinate and Fluorescein approved by the US FDA?

Yes. The US FDA first approved Benoxinate and Fluorescein on 14 December 2017, according to Drugs@FDA.

Does Benoxinate and Fluorescein need cold chain shipping?

At least one listed presentation of Benoxinate and Fluorescein must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. ALTAFLUOR prescribing information (Altaire Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 6 December 2017

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