Label: TETRACAINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 82260-920-05, 82260-920-15
  • Packager: Bausch & Lomb Americas Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 21, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5% safely and effectively. See full prescribing information for TETRACAINE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
  • 2 DOSAGE AND ADMINISTRATION
    One drop topically in the eye(s) as needed.
  • 3 DOSAGE FORMS AND STRENGTHS
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a clear, colorless, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.
  • 4 CONTRAINDICATIONS
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Corneal Injury with Intracameral Use - Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage ...
  • 6 ADVERSE REACTIONS
    The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Injury with Intracameral Use - [see - Warnings and Precautions (5.1)] Corneal ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and ...
  • 10 OVERDOSAGE
    Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may produce permanent corneal opacification and ulceration with accompanying visual ...
  • 11 DESCRIPTION
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is a sterile, clear, colorless, topical local anesthetic for ophthalmic use only containing tetracaine hydrochloride as the active ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia. 12.3 Pharmacokinetics - The ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal ...
  • 14 CLINICAL STUDIES
    Topical administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% results in localized temporary anesthesia. The maximum effect is achieved within 10–20 seconds after instillation ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a low-density polyethylene plastic dropper bottle with a low-density ...
  • 17 PATIENT COUNSELING INFORMATION
    Eye Care Precaution - Do not touch the dropper tip to any surface as this may contaminate the solution. Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 15 mL carton
    NDC82260-920-15 - Tetracaine - Hydrochloride - Ophthalmic - Solution, USP - 0.5% (Sterile) FOR OPHTHALMIC USE - [EYE IMAGE] Rx only - 15 mL - BAUSCH + LOMB - 9780301 - MA09111
  • INGREDIENTS AND APPEARANCE
    Product Information