Benz-O-Sthetic Spray

Manufacturer
Geritrex LLC
Effective date
2017-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:36

Label at a glance#

ProductBenz O Sthetic
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with: canker sores sore mouth and throat minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances minor injury of the mouth and gums

Dosage and administration

May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat: Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.

Storage and handling

store at controlled room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Drugs Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                       Purpose
Benzocaine 20%........................Oral Anesthetic

Uses

OTC - PURPOSE SECTION

Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
canker sores

  • sore mouth and throat
  • minor dental procedures
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • minor injury of the mouth and gums

Directions

DOSAGE & ADMINISTRATION SECTION

May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.

Warnings

WARNINGS SECTION


Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.

Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.

When using this product:

  • Avoid use near eyes
  • Do not use more than recommended dosage
  • Do not go beyond 7 days usage, unless directed by your doctor/dentist

Patient: Discontinue use and consult a physician if: sore mouth symptoms do
not improve in 5 days; irritation, pain, or redness persists or worsens;
swelling, rash, or fever develops.

Other Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin

Other Information:

STORAGE AND HANDLING SECTION

store at controlled room temperature 20-25°C (68-77°F)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

WARNINGS AND PRECAUTIONS SECTION

Caution:​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
615968Benz-O-Sthetic 20 % Mucosal SprayPSN2
360348benzocaine 20 % Mucosal SprayPSN2
615968benzocaine 200 MG/ML Mucosal Spray [Benz-O-Sthetic]SBD2
360348benzocaine 200 MG/ML Mucosal SpraySCD2
615968Benz-O-Sthetic 20 % Mucosal SpraySY2
615968Benz-O-Sthetic 200 MG/ML Mucosal SpraySY2
360348benzocaine 20 % Mucosal SpraySY2

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
54162-929-022020-01-31C16284748780-19d75b9d0-6079-f424-e053-dadaa90a57ceBenz-O-Sthetic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-929-02Benz O Sthetic59 mL in 1 BOTTLE, SPRAYSPRAY592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-929BENZ O STHETIC (BENZOCAINE) SPRAY [GERITREX LLC]2Legacy NDC, 1 package rows20170929_a6476659-8b5f-4179-bd66-3b407f89f4ee.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
54162-92954162-929-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
fc3e9b98-1785-4154-ae14-62baa8fff25fa6476659-8b5f-4179-bd66-3b407f89f4ee2017-09-28WarningsExact identifier
spl id: fc3e9b98-1785-4154-ae14-62baa8fff25f
spl set id: a6476659-8b5f-4179-bd66-3b407f89f4ee

Reported adverse events (FAERS/openFDA)#

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