TOPEX- benzocaine spray, metered
Dentsply LLC. Professional Division Trading as “Sultan Healthcare”
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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.
Should not be used in individuals with a known sensitivity to benzocaine or PABA.
WARNINGS AND PRECAUTIONS
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),
- 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.
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
| TOPEX |
benzocaine spray, metered
|Labeler — Dentsply LLC. Professional Division Trading as “Sultan Healthcare” (167087753)|
|Sciarra Laboratories, Inc.||824900369||MANUFACTURE (0699-3100)|
Revised: 01/2022 Dentsply LLC. Professional Division Trading as “Sultan Healthcare”
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