TOPEX  CHERRY- benzocaine gel 
TOPEX  PINA COLADA- benzocaine gel 
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 Handicaine Stix
Unit Dose Topical Anesthetic Gel

INDICATIONS AND USAGE

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

DOSAGE AND ADMINSTRATION

  • Open unit dose tray by peeling foil lid stock from the plastic tray. Dispose of foil.
  • Using the included cotton applicator, apply the benzocaine anesthetic gel to the mucosa to achieve topical anesthesia.
  • For topical tissue anesthesia during scaling procedures, coat the scaler with the product prior to use.

DOSAGE FORMS AND STRENGTHS

Each Topex Handicaine Stix dose contains approximately 0.4g of 20% benzocaine anesthetic gel (approximately 7-9mg benzocaine per unit dose tray).

CONTRAINDICATIONS

Should not be used with 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
For professional dental use only
Topex Handicaine Stix are intended for single patient use only. Do not attempt to reuse the applicator or refill the tray.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

DESCRIPTION

Flavored 20% benzocaine gel for topical mucosa anesthesia, delivered in an easy-to-use single dose package with applicator.

STORAGE AND HANDLING

Store between 59°-86°F (15°-30°C). Protect from freezing.

PRINCIPAL DISPLAY PANEL - Cherry 24 Count Carton

cherry 24

PRINCIPAL DISPLAY PANEL - Cherry 120 Count Carton

cherry 120

PRINCIPAL DISPLAY PANEL - Pina Colada 24 Count Carton

p colada 24

PRINCIPAL DISPLAY PANEL - Pina Colada 120 Count Carton

p colada 120

TOPEX   CHERRY
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-3111
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-3111-2424 in 1 CARTON01/01/195003/31/2021
10.4 g in 1 DOSE PACK; Type 0: Not a Combination Product
2NDC:0699-3111-12120 in 1 CARTON01/01/195003/03/2021
20.4 g in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/195003/31/2021
TOPEX   PINA COLADA
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-3112
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-3112-2424 in 1 CARTON01/01/195003/31/2021
10.4 g in 1 DOSE PACK; Type 0: Not a Combination Product
2NDC:0699-3112-12120 in 1 CARTON01/01/195003/31/2021
20.4 g in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/195003/31/2021
Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
Establishment
NameAddressID/FEIBusiness Operations
Dentsply Caulk083235549MANUFACTURE(0699-3111, 0699-3112)

Revised: 12/2017
Document Id: 6b0a6c8d-74a5-497d-b53f-633f51b6f25f
Set id: 60cbe11b-eefc-448a-e053-2991aa0a2d09
Version: 2
Effective Time: 20171220
 
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"