Comfortox Benzocaine

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 00:03:11

Label at a glance#

ProductComfortox Benzocaine

Active ingredientBENZOCAINE

Label structure11 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 then 3 or 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

Benzocaine 20.0% 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

WARNINGS SECTION

For external use only

Avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask 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 then 3 or 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, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat or direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

FDA Registered: NDC No. 54723-999-01

800-693-9067

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
723562	benzocaine 20 % Topical Cream	PSN	6
723562	benzocaine 200 MG/ML Topical Cream	SCD	6
723562	benzocaine 20 % Topical Cream	SY	6

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54723-999-01	2025-01-30	C162847	48780-1	2cef2736-666f-d83d-e063-dadaa90ab31f	Comfortox B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54723-999-01	Comfortox Benzocaine	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
54723-999	COMFORTOX BENZOCAINE (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	6	Legacy NDC, 1 package rows	20231202_cfb3cb1f-255f-4319-98bb-c353cc0be00e.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Comfortox Benzocaine
Benzocaine
WATER
ARNICA MONTANA FLOWER
C13-14 ISOPARAFFIN
MEDIUM-CHAIN TRIGLYCERIDES
CETEARETH-25
CHONDROITIN SULFATE SODIUM (BOVINE)
DOCUSATE SODIUM
EMU OIL
DIETHYLENE GLYCOL MONOETHYL ETHER
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
GLYCERIN
ISOPROPYL PALMITATE
LAURETH-7
MELALEUCA ALTERNIFOLIA LEAF
DIMETHYL SULFONE
PHENOXYETHANOL
POLYACRYLAMIDE (10000 MW)
POLYSORBATE 20
SAFFLOWER OIL
STEARIC ACID
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54723-999	54723-999-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
CETEARETH-25	8FA93U5T67	IACT
CHONDROITIN SULFATE SODIUM (BOVINE)	8QTV3DTT8W	IACT
DOCUSATE SODIUM	F05Q2T2JA0	IACT
EMU OIL	344821WD61	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LAURETH-7	Z95S6G8201	IACT
MELALEUCA ALTERNIFOLIA LEAF	G43C57162K	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYACRYLAMIDE (10000 MW)	E2KR9C9V2I	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SAFFLOWER OIL	65UEH262IS	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
BENZOCAINE	U3RSY48JW5	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
0940a694-3682-847d-e063-6394a90a3f35			cfb3cb1f-255f-4319-98bb-c353cc0be00e	2023-11-03	Warnings	Exact identifier spl id: 0940a694-3682-847d-e063-6394a90a3f35 spl set id: cfb3cb1f-255f-4319-98bb-c353cc0be00e

Reported adverse events (FAERS/openFDA)#

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