BencoCaine Topical Anesthetic

Manufacturer
Benco Dental
Effective date
2026-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:30

Label at a glance#

ProductBencoCaine Topical Anesthetic
Active ingredientBENZOCAINE
Label structure10 sections

Storage and handling

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

OTC - PURPOSE SECTION

Oral Anesthetic

INDICATIONS & USAGE SECTION

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures. For Professional Use Only.

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 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: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use:

  • for teething
  • in children under 2 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

STORAGE AND HANDLING SECTION

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

INACTIVE INGREDIENT SECTION

Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display PanelDisplay Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Design PanelDesign Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435490benzocaine 20 % Oral SprayPSN1
1435490benzocaine 200 MG/ML Oral SpraySCD1
1435490benzocaine 20 % Oral SpraySY1

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-360-35BencoCaine Topical Anesthetic57 g in 1 BOTTLE, SPRAYSPRAY, METERED571

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
66975-36066975-360-35

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 Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
ndc (package): 66975-360-35
ndc (product): 66975-360
ndc11 (package): 66975036035
spl id: 4d3e03ee-6e10-c9ae-e063-6394a90a6f5b
spl set id: 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b

Reported adverse events (FAERS/openFDA)#

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