FDA Label for Topex
View Indications, Usage & Precautions
Topex Product Label
The following document was submitted to the FDA by the labeler of this product Dentsply Llc. Professional Division Trading As "sultan Healthcare". The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications And Usage
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.
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).
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