2% Tetracaine Gel

Manufacturer: Bellus Medical, LLC
Effective date: 2026-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: monthly-update
Hydrated at: 2026-06-03 17:52:01

Label at a glance#

ProductTetracaine

Active ingredientTETRACAINE HYDROCHLORIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tetracaine HCL 2%

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA

DOSAGE & ADMINISTRATION SECTION

Uses : For the temporary relief of discomfort and pain associated with

Minor burns and skin irritations
Minor cuts and scrapes
Itching

Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

WARNINGS SECTION

Warnings : For external use only. Avoid contact with the eyes.

DO NOT USE : In large quantities, particularly over raw surfaces and blistered areas.

Stop use and ask a doctor if:

Skin becomes irritated
Condition worsens or symptoms last more than 7 days
Symptoms clear up and reoccur within a few days.

OTC - PURPOSE SECTION

Topical Anesthetic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Uses : For the temporary relief of discomfort and pain associated with

Minor burns and skin irritations
Minor cuts and scrapes
Itching

Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLT_4ml_Packet_T_170613 JPEG

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TETRACAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a26f29b9-6919-4f09-a354-491df8d2b97d	Product name	1	20251021
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
122d1fa8-7b9e-49b4-89ce-b062ffd1d947	Product name	1	20181030
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71888-103-02	2023-10-27	C162847	48780-1	9d75b9d0-c5f2-f424-e053-dadaa90a57ce	2% Tetracaine Gel
71888-103-02	2023-10-27	C162847	48780-1	9d75b9d0-c5f2-f424-e053-dadaa90a57ce	2% Tetracaine Gel
71888-103-02	2020-01-31	C162847	48780-1	9d75b9d0-c5f2-f424-e053-dadaa90a57ce	2% Tetracaine Gel
71888-103-02	2020-01-31	C162847	48780-1	9d75b9d0-c5f2-f424-e053-dadaa90a57ce	2% Tetracaine Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71888-103-01	Tetracaine	4 mL in 1 PACKET	GEL	4		4
71888-103-02	Tetracaine	12 in 1 BOX	GEL	12		4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Tetracaine
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
CAPRYLYL GLYCOL
EDETATE SODIUM
EDETIC ACID
GLYCERIN
PROPYLENE GLYCOL
PHENOXYETHANOL
WATER
ALOE VERA LEAF
SORBIC ACID
TETRACAINE HYDROCHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71888-103	71888-103-01, 71888-103-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
EDETATE SODIUM	MP1J8420LU	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
WATER	059QF0KO0R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SORBIC ACID	X045WJ989B	IACT
TETRACAINE HYDROCHLORIDE	5NF5D4OPCI	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2024-11-18	full-release	2026-06-01 00:37:49

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracaine	TETRACAINE	Bellus Medical, LLC	60cabb5f-606b-7a74-e053-2a91aa0ac024	2026-01-09	Warnings	Exact identifier ndc (package): 71888-103-01 ndc (package): 71888-103-02 ndc (product): 71888-103 ndc11 (package): 71888010301 ndc11 (package): 71888010302 spl id: 47faba68-aab7-7eb8-e063-6294a90a3931 spl set id: 60cabb5f-606b-7a74-e053-2a91aa0ac024

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.