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.

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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.

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

Cherry carton

TOPEX 
benzocaine spray, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-3100
Route of AdministrationPERIODONTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
BENZALDEHYDE (UNII: TA269SD04T)  
APAFLURANE (UNII: R40P36GDK6)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-3100-021 in 1 CARTON01/01/1974
157 g in 1 CANISTER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/1974
Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
Establishment
NameAddressID/FEIBusiness Operations
Sciarra Laboratories, Inc.824900369MANUFACTURE(0699-3100)

Revised: 2/2024
Document Id: d2f0a163-10c1-411b-91df-d19ec06a3003
Set id: 60c87af2-1dc5-2daf-e053-2a91aa0a7555
Version: 6
Effective Time: 20240207
 
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"