TOPEX PINA COLADA- benzocaine gel, dentifrice TOPEX CHERRY- benzocaine gel, dentifrice TOPEX MINT- benzocaine gel, dentifrice TOPEX BUBBLE GUM- benzocaine gel, dentifrice TOPEX STRAWBERRY- benzocaine gel, dentifrice TOPEX RASPBERRY- benzocaine gel, dentifrice

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", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TOPEX  PINA COLADA
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0699-7001
Route of Administration	DENTAL

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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	COCONUT (Pina Colada)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7001-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7021
Route of Administration	DENTAL

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
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7021-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7011
Route of Administration	DENTAL

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
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
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7011-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7031
Route of Administration	DENTAL

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
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
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7031-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7051
Route of Administration	DENTAL

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
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
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7051-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7061
Route of Administration	DENTAL

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
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
Color	red	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7061-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7071
Route of Administration	DENTAL

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
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7071-01	100 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7081
Route of Administration	DENTAL

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
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
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7081-01	100 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7091
Route of Administration	DENTAL

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
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	COCONUT (Pina Colada)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7091-01	100 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Item Code (Source)	NDC: 0699-7100
Route of Administration	DENTAL

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
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
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-7100-01	100 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963

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	Business 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)