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Topex Gel Prescribing Information

Package insert / product label
Generic name: benzocaine
Dosage form: gel, dentifrice
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

DIRECTIONS FOR USE

Gel – 1oz/30mL
AD31001 Cherry
AD31002 Mint
AD31004 Pina Colada
AD31005 Bubble-Num
AD31006 Strawberry
AD31007 Razzberry

Gel – 100g jar
AD31064 Cherry
AD31964 Mint
AD31067 Pina Colada
AD31068 Bubble-Num

For dental use only.
Rx only.

1. Indications and Usage for Topex Gel

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 intraoral radiographs. Apply as required.

2. Topex Gel Dosage and Administration

  1. Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle
  2. Tightly re-cap the jar after each use.

3. Dosage Forms and Strengths

Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base.

4. Contraindications

Do not use onindividuals with a known sensitivity to benzocaine or PABA.

5. 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
Take care not to contaminate the jar by reintroducing a used cotton applicator into the jar

6. Overdosage

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

7. Topex Gel Description

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

8. Storage and Handling

Topex 20% benzocaine gel is supplied in multiple use containers.

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

MANUFACTURED FOR

Sultan Healthcare

1301 Smile Way • York, PA 17404 • USA

Toll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA
0031001DF, R4-072017

PRINCIPAL DISPLAY PANEL - Cherry 34 Gram

Cherry 1 oz

PRINCIPAL DISPLAY PANEL - Mint 34 gram

Mint 1 oz

PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram

P Colada 1 oz

PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram

B Num 1 oz

PRINCIPAL DISPLAY PANEL - Strawberry 34 gram

Strawberry 1 oz

PRINCIPAL DISPLAY PANEL - Razzberry 34 gram

Razzberry 1 oz

PRINCIPAL DISPLAY PANEL - Cherry 100 gram

Cherry 100 gram

PRINCIPAL DISPLAY PANEL - Mint 100 gram

Mint 100 g

PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram

P Colada 100 g

PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram

B Num 100 g

TOPEX PINA COLADA
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7001
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
Product Characteristics
ColorWHITEScore
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7001-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/196304/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/196304/14/2023
TOPEX CHERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7021
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Product Characteristics
ColorREDScore
ShapeSize
FlavorCHERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7021-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX MINT
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7011
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
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
Product Characteristics
ColorGREENScore
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7011-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7031
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Product Characteristics
ColorPINKScore
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7031-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX STRAWBERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7051
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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
ColorREDScore
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7051-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX RASPBERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7061
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)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
Product Characteristics
ColorREDScore
ShapeSize
FlavorRASPBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7061-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/196309/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/196309/11/2022
TOPEX CHERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7071
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)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
ColorREDScore
ShapeSize
FlavorCHERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7071-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX MINT
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7081
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)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
Product Characteristics
ColorGREENScore
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7081-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPEX PINA COLADA
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7091
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:0699-7091-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/196302/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/196302/28/2019
TOPEX BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7100
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)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
Product Characteristics
ColorPINKScore
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0699-7100-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/196301/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/196301/18/2022
Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
Establishment
NameAddressID/FEIBusiness Operations
Dentsply Caulk083235549MANUFACTURE(0699-7001, 0699-7011, 0699-7021, 0699-7031, 0699-7051, 0699-7061, 0699-7071, 0699-7081, 0699-7091, 0699-7100)