MedPath

Tetracaine

Generic Name
Tetracaine
Brand Names
Ametop, Cetacaine, Kovanaze, One Touch Reformulated Apr 2009, Pliaglis, Synera, Zap
Drug Type
Small Molecule
Chemical Formula
C15H24N2O2
CAS Number
94-24-6
Unique Ingredient Identifier
0619F35CGV

Overview

Tetracaine is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.

Indication

Ophthalmic tetracaine is indicated for the for procedures requiring a rapid and short- acting topical ophthalmic anesthetic. The combination lidocaine and tetracaine patch is indicated for local dermal analgesia for superficial dermatological procedures and superficial venous access. The combination lidocaine and tetracaine cream is intended to provide topical local analgesia for superficial dermatological procedures.

Associated Conditions

  • Dermabrasion
  • Haemorrhoids
  • Insect Bites
  • Rash caused by poison ivy
  • Sunburn
  • Minor burns

Research Report

Published: Aug 7, 2025

A Comprehensive Monograph on Tetracaine (Amethocaine): Pharmacology, Clinical Utility, and Safety Profile

Section 1: Identification and Historical Context

This section establishes the fundamental identity of Tetracaine, detailing its nomenclature, classification, and unique identifiers. It further places the drug within its historical and regulatory context, from its synthesis in the early 20th century to its modern status as an essential medicine.

1.1 Nomenclature and Chemical Classification

The local anesthetic Tetracaine is recognized globally by several names. Its United States Adopted Name (USAN) is Tetracaine, while its International Nonproprietary Name (INN) is Amethocaine.[1] Historically and commercially, it has also been known by various trade names, including Pontocaine, Dicaine, and Ametop.[1]

Chemically, its systematic International Union of Pure and Applied Chemistry (IUPAC) name is 2-(dimethylamino)ethyl 4-(butylamino)benzoate.[2] Tetracaine is classified as a local anesthetic belonging to the amino-ester class, a categorization critical to understanding its metabolic pathway, duration of action, and potential for allergic reactions.[1] It is specifically a benzoate ester, formed through the chemical combination of a lipophilic aromatic acid (4-N-butylbenzoic acid) and a hydrophilic amino alcohol (2-(dimethylamino)ethanol).[2] This amphipathic structure, possessing both fat-soluble and water-soluble components, is the archetypal design for local anesthetic agents and is fundamental to its ability to interact with and block neuronal membranes.

1.2 Key Identification Codes

For unambiguous identification in global databases, regulatory filings, and scientific literature, Tetracaine and its hydrochloride salt are assigned a comprehensive set of unique identifiers. These codes are essential for accurate cross-referencing and data retrieval.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/03/12
Early Phase 1
Active, not recruiting
Our Lady of the Lake Hospital
2020/12/28
Phase 3
Completed
2020/01/30
Phase 1
Completed
2019/12/05
Not Applicable
Completed
INTEGRIS Southwest Medical Center
2019/02/18
Phase 2
UNKNOWN
2018/11/21
Not Applicable
UNKNOWN
2018/04/18
Phase 4
Withdrawn
2017/12/11
Phase 4
UNKNOWN
2017/05/08
Not Applicable
Completed
2017/01/16
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Oceanside Pharmaceuticals
68682-920
OPHTHALMIC
5 mg in 1 mL
2/28/2022
Bryant Ranch Prepack
63629-9160
ORAL
10 mg in 1 mL
2/2/2022
REMEDYREPACK INC.
70518-4183
OPHTHALMIC
5 mg in 1 mL
5/22/2025
Innovida Pharmaceutique Corporation
71800-631
TOPICAL
70 mg in 1 g
10/20/2021
NuCare Pharmaceuticals,Inc.
68071-5079
OPHTHALMIC
5 mg in 1 mL
2/19/2021
Bausch & Lomb Incorporated
24208-092
OPHTHALMIC
5 mg in 1 mL
5/31/2022
Akorn
17478-045
SUBARACHNOID
10 mg in 1 mL
4/14/2010
St. Renatus
69803-100
NASAL
30 mg in 1 mL
11/16/2018
Sincerus Florida, LLC
72934-2140
TOPICAL
7 g in 100 g
6/4/2020
Cetylite Industries, Inc.
10223-0202
TOPICAL
0.004 g in 0.2 g
5/11/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 1% w/v
SIN04204P
SOLUTION
0.01g/mL
4/12/1990
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 0.5% w/v
SIN04188P
SOLUTION
0.005g/mL
4/14/1990
PLIAGLIS CREAM 70mg/g + 70mg/g
SIN14793P
CREAM
7.00% w/w
6/2/2015

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SUPRACAINE AEM 754MG/65GM
hoechst canada inc.
00763667
Metered-Dose Aerosol - Dental
754 MG / 65 G
12/31/1988
SPINAL ANESTHESIA TRAY
baxter corporation
01909509
Liquid - Subcutaneous ,  Block/Infiltration
1 % / KIT
12/31/1992
PONTOCAINE
hospira healthcare ulc
02241978
Powder For Solution - Intraspinal
20 MG / 2 ML
7/15/2001
DERMACAINE-R
innovatech inc
02344971
Cream - Topical
2 % / W/W
N/A
CETACAINE LIQUID
cetylite industries inc.
02028867
Liquid - Topical
2 %
9/19/1996
SUPRACAINE AEROSOL 11.6MG/GM
hoechst roussel canada inc.
01987593
Metered-Dose Aerosol - Topical ,  Oral
11.6 MG / G
12/31/1993
SPINAL ANESTHESIA TRAY
baxter corporation
01975463
Liquid - Block/Infiltration
1 % / KIT
12/31/1992
ZAP TOPICAL ANESTHETIC GEL
01930699
Gel - Topical
2 %
12/31/1992
TRUE TEST
02271885
Patch - Topical
0.073 MG
3/16/2006
VIRACTIN MOISTURIZING CREAM
medibrands israel (subsidiary of mediline ltd)
02236789
Cream - Topical
2 %
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.