Topex Topical Anesthetic Metered Spray

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:

• Not for use in children under 2 years of age. • Keep out of reach of children.

• pale, gray, or blue colored skin (cyanosis),
• headache,
• rapid heart rate,
• shortness of breath,
• dizziness or lightheadedness,
• fatigue or lack of energy

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).