TETRACAINE HCL OPTH 0.5% 15ML
Generic: Tetracaine Hydrochloride
TETRACAINE HCL OPTH 0.5% 15ML
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
Tetracaine Hydrochloride
Tetracaine Hydrochloride
Oceanside Pharmaceuticals
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION/ DROPS
OPHTHALMIC
NDA210821
Active Ingredients
| Ingredient | Strength |
|---|---|
| TETRACAINE HYDROCHLORIDE | 5 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION One drop topically in the eye(s) as needed. One drop topically in the eye(s) as needed. ( 2 )
Adverse Reactions
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 Toxicity [ see Warnings and Precautions ( 5.2 )] Corneal Injury Due to Insensitivity [ see Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%. 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. Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Information for Patients
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 for up to 20 minutes and that care should be taken to avoid accidental injuries. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch Health Companies Inc. or its affiliates 9675203 (Folded) 9675303 (Flat)
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.