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Topex Gel

Generic name: benzocaine
Dosage form: gel, dentifrice

Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.

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.

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

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. 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. DESCRIPTION

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

8. HOW SUPPLIED / 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

PRINCIPAL DISPLAY PANEL - Mint 34 gram

PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram

PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram

PRINCIPAL DISPLAY PANEL - Strawberry 34 gram

PRINCIPAL DISPLAY PANEL - Razzberry 34 gram

PRINCIPAL DISPLAY PANEL - Cherry 100 gram

PRINCIPAL DISPLAY PANEL - Mint 100 gram

PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram

PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram

TOPEX PINA COLADA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7001
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM (SACCHARIN)
POLYETHYLENE GLYCOL 3350
Product Characteristics
Color white Score
Shape Size
Flavor COCONUT (Pina Colada) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7001-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX CHERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7021
Route of Administration DENTAL 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
FD&C RED NO. 40
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
WATER
POLYETHYLENE GLYCOL 400
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7021-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX MINT
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7011
Route of Administration DENTAL 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
D&C GREEN NO. 5
POLYETHYLENE GLYCOL 400
SACCHARIN SODIUM (SACCHARIN)
WATER
PEPPERMINT OIL (PEPPERMINT)
POLYETHYLENE GLYCOL 3350
Product Characteristics
Color green Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7011-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7031
Route of Administration DENTAL 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
D&C RED NO. 28
WATER
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7031-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX STRAWBERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7051
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 400
WATER
SACCHARIN SODIUM (SACCHARIN)
FD&C RED NO. 40
Product Characteristics
Color red Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7051-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX RASPBERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7061
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
FD&C RED NO. 40
D&C RED NO. 28
FD&C BLUE NO. 1
WATER
Product Characteristics
Color red Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7061-34 34 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX CHERRY
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7071
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
WATER
FD&C RED NO. 40
Product Characteristics
Color red Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7071-01 100 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX MINT
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7081
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
WATER
PEPPERMINT OIL (PEPPERMINT)
D&C GREEN NO. 5
Product Characteristics
Color green Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7081-01 100 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX PINA COLADA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7091
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white Score
Shape Size
Flavor COCONUT (Pina Colada) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7091-01 100 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
TOPEX BUBBLE GUM
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0699-7100
Route of Administration DENTAL 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
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM (SACCHARIN)
WATER
POLYETHYLENE GLYCOL 400
D&C RED NO. 28
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:0699-7100-01 100 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/19/1963
Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
Establishment
Name Address ID/FEI Operations
DENTSPLY Caulk 083235549 manufacture(0699-7001, 0699-7011, 0699-7021, 0699-7031, 0699-7051, 0699-7061, 0699-7071, 0699-7081, 0699-7091, 0699-7100)
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"