FDA.reportPublic FDA data

Topical Anesthetic Gel - 20% Benzocaine

Manufacturer
NDC, Inc. | Caulk
Effective date
2018-09-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:26:24

Label at a glance#

ProductTopical Anesthetic
Active ingredientBenzocaine
Label structure16 sections

Indications and uses

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

Dosage and administration

❖ Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle. ❖ Tightly re-cap the jar after each use.

Storage and handling

20% benzocaine gel is supplied in multiple use containers Store between 59°-86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Gel – 1oz/34g
2731001 Cherry
2731002 Mint
2731004 Pina Colada
2731005 Bubble Gum
2731006 Strawberry
2731007 Raspberry

For dental use only

Rx only

1. INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

2. DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  • Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
  • Tightly re-cap the jar after each use.

3. DOSAGE FORMS AND STRENGTH

DOSAGE FORMS & STRENGTHS SECTION

Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base.

4. CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

5. WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

METHEMOGLOBINEMIA WARNING

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient 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
  • Not for use in children under 2 years of age
  • Keep out of reach of children
  • For professional dental use only
  • Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle

6. OVERDOSAGE

OVERDOSAGE SECTION

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

7. DESCRIPTION

DESCRIPTION SECTION

Flavored 20% benzocaine gel for topical mucosa anesthesia

8. HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

20% benzocaine gel is supplied in multiple use containers

STORAGE AND HANDLING SECTION

Store between 59°-86°F (15°-30°C). Protect from freezing.

SPL UNCLASSIFIED SECTION

For more information call NDC at 1-800-929-4232
Manufactured for NDC Nashville, TN 37217
Made in the USA
2731001DF, R1-120116

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Cherry

REF: 2731001

CHERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-021-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Mint

REF: 2731002

MINT

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-023-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Piña Colada

REF: 2731004

PIÑA COLADA

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-024-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Bubble Gum

REF: 2731005

BUBBLE GUM

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-022-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Strawberry

REF: 2731006

STRAWBERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-020-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Anesthetic Gel
20% Benzocaine
Raspberry

REF: 2731007

RASPBERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-026-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry
PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN2
238910benzocaine 0.2 MG/MG Oral GelSCD2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43128-020-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine
43128-021-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine
43128-022-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine
43128-023-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine
43128-024-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine
43128-026-302020-01-31C16284748780-19d75b9d0-90b8-f424-e053-dadaa90a57ceTopical Anesthetic Gel - 20% Benzocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43128-020-30Topical Anesthetic34 g in 1 JARGEL342
43128-021-30Topical Anesthetic34 g in 1 JARGEL342
43128-022-30Topical Anesthetic34 g in 1 JARGEL342
43128-023-30Topical Anesthetic34 g in 1 JARGEL342
43128-024-30Topical Anesthetic34 g in 1 JARGEL342
43128-026-30Topical Anesthetic34 g in 1 JARGEL342

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43128-020TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip
43128-021TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip
43128-022TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip
43128-023TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip
43128-024TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip
43128-026TOPICAL ANESTHETIC (BENZOCAINE) GEL [NDC, INC.]2Legacy NDC, 1 package rows20180905_9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43128-02143128-021-30
43128-02343128-023-30
43128-02443128-024-30
43128-02243128-022-30
43128-02043128-020-30
43128-02643128-026-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
D&C GREEN NO. 58J6RDU8L9XIACT
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
D&C RED NO. 28767IP0Y5NHIACT
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
BenzocaineU3RSY48JW5ACTIB
Polyethylene Glycol 3350G2M7P15E5PIACT
Polyethylene Glycol 400B697894SGQIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT

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
a43d1c49-5d68-4811-bdd6-16eaeeb46e2f9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe2018-09-04WarningsExact identifier
spl id: a43d1c49-5d68-4811-bdd6-16eaeeb46e2f
spl set id: 9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe

Reported adverse events (FAERS/openFDA)#

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