Label: TOPEX- benzocaine gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 10216-3071-1, 10216-3081-1, 10216-3091-1, 10216-3110-1 - Packager: DENTSPLY Caulk
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated February 4, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
DIRECTIONS FOR USE
Gel – 1oz/30mL
REF AD31001 Cherry
REF AD31002 Mint
REF AD31003 Banana
REF AD31004 Pina Colada
REF AD31005 Bubble-Num
REF AD31006 Strawberry
REF AD31007 RazzberryGel – 100g jar
REF AD31064 Cherry
REF AD31964 Mint
REF AD31067 Pina Colada
REF AD31068 Bubble-NumLiquid – 1oz/30mL
REF AD31011 Cherry
REF AD31012 Mint
REF AD31014 Pina Colada USP – 2oz/57gNPN Number: 00638358
For dental use only.
USA: Rx only. - 1. DESCRIPTION
- 2. INDICATIONS
- 3. CONTRAINDICATIONS
- 4. WARNINGS
- 5. PRECAUTIONS
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6. DOSAGE AND ADMINISTRATION
- Each gram of Topex 20% benzocaine gel or liquid contains between 180-220mg benzocaine in a flavored base.
- 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.
- For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel or liquid into a dappen dish, then coat the scaler with the product prior to use.
- Tightly re-cap the jar after each use.
- 7. STORAGE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
- PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
- PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
- PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
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INGREDIENTS AND APPEARANCE
TOPEX
benzocaine gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10216-3071 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 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:10216-3071-1 100 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
benzocaine gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10216-3081 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 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:10216-3081-1 100 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
benzocaine gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10216-3091 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 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:10216-3091-1 100 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
benzocaine gel, dentifriceProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10216-3110 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 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:10216-3110-1 100 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 Caulk (083235549) Establishment Name Address ID/FEI Business Operations DENTSPLY Caulk 083235549 MANUFACTURE
