BencoCaine Topical Anesthetic

Manufacturer
Benco Dental
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:17

Label at a glance#

ProductBencoCaine Topical Anesthetic
Active ingredientBENZOCAINE
Label structure14 sections

Dosage and administration

• Apply only amount needed to the oral mucosa to prevent or relieve pain. • children under 2 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 200 mg (in each g)

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

INDICATIONS & USAGE SECTION

For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures.

Warnings

WARNINGS SECTION

Warnings
Methemoglolllnemla
warning: Use of this product
may cause methemoglobinemia,
a seriouscondit~n that must be
treated promptly because tt
reduces the amount of oxygen
carried in the 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

OTHER SAFETY INFORMATION

Allergy Alert Do not use on
patients with a history of
allergies to local anesthetics
suchasprocaine,butacaine,
benzocaine or other "caine"
anesthetics.

Do not use

OTC - DO NOT USE SECTION

•for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or worsens; or if swelling, rash or fever develops,see your physician promptly.
• for teething
•in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush with water.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a physician before use.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply only amount needed to
the oral mucosa to prevent or
relieve pain.
• children under 2 years of age:
do not use

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

flavoring, PEG 3350, PEG 400, sodium saccharin.

Questions or Comments?

OTC - QUESTIONS SECTION

800.GO.BENCO or benco.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bencocaine Topical Wrap_dye-free_99091791Bencocaine Topical Wrap_dye-free_99091791

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1541816BencoCaine 20 % Oral GelPSN2
238910benzocaine 20 % Oral GelPSN2
1541816benzocaine 0.2 MG/MG Oral Gel [Bencocaine]SBD2
238910benzocaine 0.2 MG/MG Oral GelSCD2
1541816Bencocaine 20 % Oral GelSY2
1541816Bencocaine 200 MG/GM Topical Oral GelSY2
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-340-30BencoCaine Topical Anesthetic30 g in 1 JARGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-340BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]2Current NDC, 1 package rows20250110_05cf428c-3bc8-5fcb-e063-6394a90a962a.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66975-34066975-340-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05cf428c-3bc8-5fcb-e063-6394a90a962a2025-01-08WarningsExact identifier
ndc (package): 66975-340-30
ndc (product): 66975-340
ndc11 (package): 66975034030
spl id: 2b3a4c9f-2bc9-0095-e063-6294a90af3fd
spl set id: 05cf428c-3bc8-5fcb-e063-6394a90a962a

Reported adverse events (FAERS/openFDA)#

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