Comfortox Tetracaine

Manufacturer: Sambria Pharmaceuticals, Inc. | A.I.G. Technologies, Inc.
Effective date: 2023-11-03
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:03:07

Label at a glance#

ProductComfortox Tetracaine

Active ingredientTETRACAINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

For temporary relief of pain and itching due to minor skin irritation

Dosage and administration

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Contacts and useful links#

PhoneLabel contact800-693-9067

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Tetracaine HCL 2.0% w/w

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to minor skin irritation

WARNINGS SECTION

For external use only

Avoid contact with eyes

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas

OTC - STOP USE SECTION

Stop use and ask a doctor if

• Condition worsens, or if symptoms persist for more then 7 days or clear up and occur again within a few days. Discontinue use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

FDA Registered: NDC No. 54723-997-01

800-693-9067

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1543158	tetracaine HCl 2 % Topical Cream	PSN	6
1543158	tetracaine hydrochloride 20 MG/ML Topical Cream	SCD	6
1543158	tetracaine HCl 2 % Topical Cream	SY	6

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
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
54723-997-01	2025-01-30	C162847	48780-1	2cef2736-99ea-d83d-e063-dadaa90ab31f	Comfortox T

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54723-997-01	Comfortox Tetracaine	1500 mg in 1 PACKET	CREAM	1500		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54723-997	COMFORTOX TETRACAINE (TETRACAINE HCL) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	6	Legacy NDC, 1 package rows	20231202_90f644b4-faa2-4f54-865a-44ccdab99ad3.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Comfortox Tetracaine
Tetracaine HCL
WATER
ARNICA MONTANA FLOWER
C13-14 ISOPARAFFIN
CHONDROITIN SULFATE SODIUM (BOVINE)
EMU OIL
DIETHYLENE GLYCOL MONOETHYL ETHER
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
ISOPROPYL PALMITATE
LAURETH-7
MELALEUCA ALTERNIFOLIA LEAF
DIMETHYL SULFONE
PHENOXYETHANOL
PROPYLENE GLYCOL
STEARIC ACID
TROLAMINE
TETRACAINE HYDROCHLORIDE
TETRACAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54723-997	54723-997-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
CHONDROITIN SULFATE SODIUM (BOVINE)	8QTV3DTT8W	IACT
EMU OIL	344821WD61	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LAURETH-7	Z95S6G8201	IACT
MELALEUCA ALTERNIFOLIA LEAF	G43C57162K	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
TETRACAINE HYDROCHLORIDE	5NF5D4OPCI	ACTIB

Source Document#

Source XML

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
094099ac-1a05-7d6b-e063-6394a90a936b			90f644b4-faa2-4f54-865a-44ccdab99ad3	2023-11-03	Warnings	Exact identifier spl id: 094099ac-1a05-7d6b-e063-6394a90a936b spl set id: 90f644b4-faa2-4f54-865a-44ccdab99ad3

Reported adverse events (FAERS/openFDA)#

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