TOPEX- benzocaine spray, metered

Topex by

Drug Labeling and Warnings

Topex by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC. Professional Division Trading as "Sultan Healthcare", Sciarra Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TOPEX 
benzocaine spray, metered

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BENZALDEHYDE (UNII: TA269SD04T)
APAFLURANE (UNII: R40P36GDK6)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-3100-02	1 in 1 CARTON	01/01/1900
1		57 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/1900

Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)

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