Fluorescein Sodium and Benoxinate Hydrochloride 4.4 mg/mL
Fluorescein Sodium and Benoxinate Hydrochloride · SOLUTION/ DROPS · Bausch & Lomb Americas Inc.
Fluorescein Sodium and Benoxinate Hydrochloride is a solution/ drops containing fluorescein sodium and benoxinate hydrochloride at 4.4 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Americas Inc..
Key Facts
- Brand Name
- Fluorescein Sodium and Benoxinate Hydrochloride
- Generic Name
- Fluorescein Sodium and Benoxinate Hydrochloride
- NDC Code (Product)
82260-734- Manufacturer
- Bausch & Lomb Americas Inc.
- Strength
- 4.4 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA211039
- Marketing Start
- 03/20/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 )
Contraindications
4 CONTRAINDICATIONS 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. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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.
Frequently Asked Questions
What is Fluorescein Sodium and Benoxinate Hydrochloride used for?
Fluorescein Sodium and Benoxinate Hydrochloride contains Fluorescein Sodium and Benoxinate Hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Fluorescein Sodium and Benoxinate Hydrochloride a controlled substance?
Fluorescein Sodium and Benoxinate Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Fluorescein Sodium and Benoxinate Hydrochloride?
The generic name for Fluorescein Sodium and Benoxinate Hydrochloride is Fluorescein Sodium and Benoxinate Hydrochloride. There are 1 other brand versions of Fluorescein Sodium and Benoxinate Hydrochloride.
What is the NDC code for Fluorescein Sodium and Benoxinate Hydrochloride 4.4 mg/mL?
The NDC (National Drug Code) for Fluorescein Sodium and Benoxinate Hydrochloride 4.4 mg/mL is 82260-734, listed by Bausch & Lomb Americas Inc..