Description
NDC: 70069-596-01
Tetracaine HCl 0.5% Ophthalmic Solution, 5 mL — Somerset Therapeutics
| Active ingredient | Tetracaine hydrochloride 0.5% |
| Dosage form | Ophthalmic solution |
| Route | Topical ophthalmic |
| Size | 5 mL |
| Manufacturer | Somerset Therapeutics |
| NDC | 70069-596-01 |
Indications and Usage
A topical ophthalmic anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
Dosage and Administration
Instill one drop topically in the affected eye(s) as needed. It should be administered under the direct supervision of a healthcare provider.
Warnings and Precautions
- Not for injection or intraocular use
- For topical ophthalmic use only; prolonged use or abuse may cause corneal epithelial toxicity and permanent corneal opacification with vision loss
- Patients should avoid touching the eye for at least 10 to 20 minutes while anesthesia persists to prevent inadvertent injury
- Use with caution in patients with cardiac disease or hyperthyroidism
Contraindications
Contraindicated in patients with known hypersensitivity to tetracaine or any component of the preparation.
Adverse Reactions
The most common adverse reactions are transient stinging, burning, and conjunctival redness, as well as eye irritation, eye pain, and ocular discomfort.
Storage and Handling
Store at 15°C to 25°C (59°F to 77°F). Protect from light. Do not use if the solution contains crystals or is cloudy or discolored.
How Supplied
Supplied as a sterile 0.5% tetracaine hydrochloride ophthalmic solution in a 5 mL bottle.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
