FDA.reportPublic FDA data

DenTek Instant Pain Relief

Manufacturer
DenTek Oral Care, Inc.
Effective date
2021-10-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:42:43

Label at a glance#

ProductDenTek Instant Pain Relief Maximum Strength
Active ingredientBENZOCAINE
Label structure9 sections

Dosage and administration

dip applicator into liquid Adults and children 2 years 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 between 2 and 12 years Should be supervised in the use of this product. Children under 2 years Do not use.      

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain due to:

  • toothaches
  • canker sores
  • cold sores
  • sore gums

Warnings

WARNINGS SECTION

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

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

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2 years of age

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 directed by a doctor/dentist

Stop use and ask a dentist or doctor if 

OTC - ASK DOCTOR 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

dip applicator into liquid

Adults and children 2 years and olderApply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children between 2 and 12 years Should be supervised in the use of this product.
Children under 2 years Do not use.

     

Other information

OTHER SAFETY INFORMATION

  • for toothaches, use only as a temporary remedy until a dentist can be seen
  • store at 20-25⁰C (68-77⁰F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose 

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DenTek™ 

INSTANT PAIN RELIEF

Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLEPRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE PRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLEPRINCIPAL DISPLAY PANEL DenTek™ INSTANT PAIN RELIEF Benzocaine 20% / ORAL ANESTHETIC 1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN6
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD6
308657benzocaine 20 % Mucous Membrane Topical SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60630-077-042025-01-30C16284748780-12cef2736-60a3-d83d-e063-dadaa90ab31fDENTEK INSTANT PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-077-03DenTek Instant Pain ReliefMaximum Strength3.5 mL in 1 VIAL, GLASSLIQUID3.56
60630-077-04DenTek Instant Pain ReliefMaximum Strength1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60630-077DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE, INC.]6Legacy NDC, 2 package rows20211014_3a3468b4-0625-71cd-e054-00144ff8d46c.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60630-07760630-077-03, 60630-077-04

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
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
PEPPERMINT OILAV092KU4JHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SPEARMINT OILC3M81465G5IACT
SUCRALOSE96K6UQ3ZD4IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bd751b9a-a6c1-47ca-8c3d-32d3ad657c2c3a3468b4-0625-71cd-e054-00144ff8d46c2021-10-18WarningsExact identifier
spl id: bd751b9a-a6c1-47ca-8c3d-32d3ad657c2c
spl set id: 3a3468b4-0625-71cd-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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