FDA.reportPublic FDA data

Topex Topical Anesthetic Metered Spray

Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | Sciarra Laboratories, Inc.
Effective date
2024-02-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 20:59:31

Label at a glance#

ProductTopex
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

Topical anesthetic for use on oral mucosa

Dosage and administration

Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.

Storage and handling

Store between 59°-86°F (15°-30°C).

Label contents#

Full prescribing information#

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Topical anesthetic for use on oral mucosa

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.

DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Each gram of Topex 20% benzocaine topical anesthetic spray contains between 180-220 mg benzocaine. Each metered spray delivers approximately 6.8 mg of benzocaine.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

METHEMOGLOBINEMIA WARNING:
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.

OVERDOSAGE

OVERDOSAGE SECTION

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

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Store between 59°-86°F (15°-30°C).

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cherry cartonCherry carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
360348benzocaine 20 % Mucosal SprayPSN6
360348benzocaine 200 MG/ML Mucosal SpraySCD6
360348benzocaine 20 % Mucosal SpraySY6

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
0699-3100-022025-07-29C16284748780-11030e365-0e66-111a-e063-dadaa90a10e2Topex Topical Anesthetic Metered Spray
0699-3100-022024-02-07C16284748780-11030e365-0e66-111a-e063-dadaa90a10e2Topex Topical Anesthetic Metered Spray
0699-3100-022024-01-30C16284748780-11030e365-0e66-111a-e063-dadaa90a10e2Topex Topical Anesthetic Metered Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0699-3100-02Topex1 in 1 CARTONSPRAY, METERED16
0699-3100-02Topex57 g in 1 CANISTERSPRAY, METERED576

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0699-3100TOPEX (BENZOCAINE) SPRAY, METERED [DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "SULTAN HEALTHCARE"]6Legacy NDC, 2 package rows20240208_60c87af2-1dc5-2daf-e053-2a91aa0a7555.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0699-3100-02GM - Gram0699-3100fb8f3a18-06d2-45db-a828-e51138583b2a12018-01-12

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
0699-31000699-3100-02

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
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BENZALDEHYDETA269SD04TIACT
APAFLURANER40P36GDK6IACT

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
d2f0a163-10c1-411b-91df-d19ec06a300360c87af2-1dc5-2daf-e053-2a91aa0a75552024-02-07WarningsExact identifier
spl id: d2f0a163-10c1-411b-91df-d19ec06a3003
spl set id: 60c87af2-1dc5-2daf-e053-2a91aa0a7555

Reported adverse events (FAERS/openFDA)#

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