Topex

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.

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

TOPEX benzocaine spray, metered

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-3100 Route of Administration PERIODONTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (BENZOCAINE) BENZOCAINE 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 BENZALDEHYDE APAFLURANE

Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0699-3100-02 1 CANISTER in 1 CARTON contains a CANISTER 1 57 g in 1 CANISTER This package is contained within the CARTON (0699-3100-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/1974

Labeler — Dentsply LLC. Professional Division Trading as “Sultan Healthcare” (167087753)

Establishment
Name	Address	ID/FEI	Operations
Sciarra Laboratories, Inc.		824900369	MANUFACTURE (0699-3100)

Revised: 01/2022 Dentsply LLC. Professional Division Trading as “Sultan Healthcare”