Indications And Usage
Topical anesthetic for use on oral mucosa
Topex
FDA Label NDC 0699-3100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dentsply Llc. Professional Division Trading As "sultan Healthcare" for the product Topex (NDC 0699-3100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings and precautions, overdosage, storage and handling, principal display panel - carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage And Administration
Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.
Dosage Forms And Strengths
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
Should not be used in individuals with a known sensitivity to benzocaine or PABA.
Warnings And Precautions
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
In case of overdose, get medical help or contact a Poison Control Center right away.
Storage And Handling
Store between 59°-86°F (15°-30°C).
Principal Display Panel - Carton
Cherry Carton (Cherry 01)
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