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NDC 00699-7001-34 Topex 220 mg/g Details

Topex 220 mg/g

Topex is a DENTAL GEL, DENTIFRICE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dentsply LLC. Professional Division Trading as "Sultan Healthcare". The primary component is BENZOCAINE.

Product Information

NDC	00699-7001
Product ID	0699-7001_a07891e5-c90e-4a6a-b592-75f696809e71
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Topex
Proprietary Name Suffix	Pina Colada
Non-Proprietary Name	Benzocaine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL, DENTIFRICE
Route	DENTAL
Active Ingredient Strength	220
Active Ingredient Units	mg/g
Substance Name	BENZOCAINE
Labeler Name	Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00699-7001-34 (00699700134)

Pricing Information	N/A
NDC Package Code	0699-7001-34
Billing NDC	00699700134
Package	34 g in 1 JAR (0699-7001-34)
Marketing Start Date	1963-02-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 87083cc6-fedc-4676-84e1-3134f690dfa9 Details

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

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
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0699-7061-34	34 g in 1 JAR; Type 0: Not a Combination Product	02/19/1963	09/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		02/19/1963	09/11/2022