Dentek Instant Pain Relief

Manufacturer: IIMED MEDICAL MEXICANA S. DE R.L. DE C.V
Effective date: 2023-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:56:28

Label at a glance#

ProductDentek Instant Pain Relief Maximum Strength

Active ingredientBENZOCAINE

Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to:

toothaches
canker sore
cold sores
sore gums

Warnings

WARNINGS SECTION

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.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

swelling, rash or fever develops
irritation, pain or redness persists or worsens
symptoms do not improve in 7 days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 information

OTHER SAFETY 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 ingredients

INACTIVE INGREDIENT SECTION

Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Questions or comments?

OTC - QUESTIONS SECTION

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

Entire Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308657	benzocaine 20 % Mucous Membrane Topical Solution	PSN	2
308657	benzocaine 200 MG/ML Mucous Membrane Topical Solution	SCD	2
308657	benzocaine 20 % Mucous Membrane Topical Solution	SY	2

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
83062-410-04	2025-01-30	C162847	48780-1	2cef2736-8656-d83d-e063-dadaa90ab31f	IIMED Dentek Instant Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83062-410-03	Dentek Instant Pain ReliefMaximum Strength	3.5 mL in 1 VIAL, GLASS	LIQUID	3.5		2
83062-410-04	Dentek Instant Pain ReliefMaximum Strength	1 in 1 CARTON	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83062-410	DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [IIMED MEDICAL MEXICANA S. DE R.L. DE C.V]	2	Legacy NDC, 2 package rows	20231006_eab430c5-f8e4-1132-e053-2a95a90aee2d.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
PEPPERMINT OIL
SUCRALOSE
SPEARMINT OIL
POLYETHYLENE GLYCOL 400

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83062-410	83062-410-03, 83062-410-04
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
PEPPERMINT OIL	AV092KU4JH	IACT
SUCRALOSE	96K6UQ3ZD4	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
06ffc47c-5591-1ca9-e063-6394a90abda5			eab430c5-f8e4-1132-e053-2a95a90aee2d	2023-10-05	Warnings	Exact identifier spl id: 06ffc47c-5591-1ca9-e063-6394a90abda5 spl set id: eab430c5-f8e4-1132-e053-2a95a90aee2d

Reported adverse events (FAERS/openFDA)#

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