Tetracaine Hydrochloride 5 mg/mL
Tetracaine Hydrochloride · SOLUTION · Somerset Therapeutics, LLC
Tetracaine Hydrochloride is a solution containing tetracaine hydrochloride at 5 mg/mL, taken ophthalmic. Manufactured by Somerset Therapeutics, LLC.
Key Facts
- Brand Name
- Tetracaine Hydrochloride
- Generic Name
- Tetracaine Hydrochloride
- NDC Code (Product)
70069-597- Manufacturer
- Somerset Therapeutics, LLC
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA217227
- Marketing Start
- 12/23/2024
Recall History
Fagron, Inc
Microbial contamination of non-sterile product.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 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. Discard unused portion. ( 2.1 ) 2.1 Topical Administration One drop topically in the eye as needed. Discard unused portion. 2.2 Sterile Field Administration Open package using standard aseptic technique. The DROP‑TAINER ® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROP‑TAINER ® dispenser and its contents are sterile.
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
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 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: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Tetracaine Hydrochloride used for?
Tetracaine Hydrochloride contains Tetracaine Hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Tetracaine Hydrochloride a controlled substance?
Tetracaine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Tetracaine Hydrochloride?
The generic name for Tetracaine Hydrochloride is Tetracaine Hydrochloride. There are no other listed brand versions of Tetracaine Hydrochloride.
What is the NDC code for Tetracaine Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Tetracaine Hydrochloride 5 mg/mL is 70069-597, listed by Somerset Therapeutics, LLC.
Other Tetracaine Hydrochloride Dosages
- Tetracaine Hydrochloride5 mg/mL70518-4183
- Tetracaine Hydrochloride5 mg/mL0065-0741
- Tetracaine Hydrochloride5 mg/mL24208-092
- Tetracaine Hydrochloride5 mg/mL0187-0920
- Tetracaine Hydrochloride5 mg/mL68682-920
- Tetracaine Hydrochloride5 mg/mL50090-2364
- Tetracaine Hydrochloride5 mg/mL82260-920
- Tetracaine Hydrochloride5 mg/mL70069-596
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)