Topex Handicaine Stix Unit Dose Topical Anesthetic Gel

Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | Dentsply Caulk
Effective date
2017-12-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:06:09

Label at a glance#

ProductTopex Cherry
Active ingredientBENZOCAINE
Label structure12 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.

Storage and handling

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

Label contents#

Full prescribing information#

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.

DOSAGE AND ADMINSTRATION

DOSAGE & ADMINISTRATION SECTION

  • Open unit dose tray by peeling foil lid stock from the plastic tray. Dispose of foil.
  • Using the included cotton applicator, apply the benzocaine anesthetic gel to the mucosa to achieve topical anesthesia.
  • For topical tissue anesthesia during scaling procedures, coat the scaler with the product prior to use.

DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Each Topex Handicaine Stix dose contains approximately 0.4g of 20% benzocaine anesthetic gel (approximately 7-9mg benzocaine per unit dose tray).

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Should not be used with 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
For professional dental use only
Topex Handicaine Stix are intended for single patient use only. Do not attempt to reuse the applicator or refill the tray.

OVERDOSAGE

OVERDOSAGE SECTION

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

DESCRIPTION

DESCRIPTION SECTION

Flavored 20% benzocaine gel for topical mucosa anesthesia, delivered in an easy-to-use single dose package with applicator.

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - Cherry 24 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cherry 24cherry 24

PRINCIPAL DISPLAY PANEL - Cherry 120 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cherry 120cherry 120

PRINCIPAL DISPLAY PANEL - Pina Colada 24 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

p colada 24p colada 24

PRINCIPAL DISPLAY PANEL - Pina Colada 120 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

p colada 120p colada 120

FDA-Initiated Inactive NDC Indexing#

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
0699-31110699-3111-24, 0699-3111-12
0699-31120699-3112-24, 0699-3112-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6b0a6c8d-74a5-497d-b53f-633f51b6f25f60cbe11b-eefc-448a-e053-2991aa0a2d092017-12-20WarningsExact identifier
spl set id: 60cbe11b-eefc-448a-e053-2991aa0a2d09

Reported adverse events (FAERS/openFDA)#

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