Label at a glance#

ProductDenTek Instant Pain Relief Maximum Strength

Active ingredientBENZOCAINE

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzocaine 20%

OTC - PURPOSE SECTION

Purpose

Oral Pain Reliever

INDICATIONS & USAGE SECTION

Use for the temporary relief of pain due to: . toothaches . canker sore . cold sores . sore gums

WARNINGS SECTION

Warnings

Allergy alert: do not use this product if you have a history of allery to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

OTC - WHEN USING SECTION

When using this product . avoid contact with the eyes . do not exceed recommended dosage . do not use for more than 7 days unless directed by a doctor/dentist

OTC - STOP USE SECTION

Stop use and ask a dentist or doctor if. swelling, rash or fever develops . irritation, pain or redness persists or worsens . symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions. dip applicator into liquid

Adults and children 2 years of age and older: Apply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age: Should be supervised in the use of this product.

Children under 2 years of age: Ask a dentist or doctor.

OTHER SAFETY INFORMATION

Other information . do not use if safety seal on carton is broken. . this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. . do not use continuously

INACTIVE INGREDIENT SECTION

Inactive ingredients: Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

OTC - QUESTIONS SECTION

Questions or comments? Call us 800-4DENTEK (433-6835) M-F 8am - 5pm EST or email us at info@DenTek.com

DenTek Instant Pain Relief Inner Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Vial Label DenTek Oral Pain Reliever

DenTek Instant Pain Relief Outer Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

adult pain relief outer carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	6
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	6
308657	benzocaine 20 % Mucous Membrane Topical Solution	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
67659-410-04	2024-01-30	C162847	48780-1	1030e365-2ebe-111a-e063-dadaa90a10e2	DenTek Instant Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67659-410-03	DenTek Instant Pain ReliefMaximum Strength	3.5 mL in 1 VIAL, GLASS	LIQUID	3.5		6
67659-410-04	DenTek Instant Pain ReliefMaximum Strength	1 in 1 CARTON	LIQUID	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67659-410	DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TEAM TECHNOLOGIES, INC]	6	Legacy NDC, 2 package rows	20221014_3afd5a15-02db-27d3-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

DenTek Instant Pain Relief Maximum Strength
Benzocaine
SUCRALOSE
PEPPERMINT OIL
SPEARMINT OIL
POLYETHYLENE GLYCOL 400

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67659-410	67659-410-03, 67659-410-04
60630-077

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCRALOSE	96K6UQ3ZD4	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SPEARMINT OIL	C3M81465G5	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	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
eaf10df8-48f1-c36f-e053-2a95a90abf45			3afd5a15-02db-27d3-e054-00144ff88e88	2022-10-13	Warnings	Exact identifier spl id: eaf10df8-48f1-c36f-e053-2a95a90abf45 spl set id: 3afd5a15-02db-27d3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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