Label: TOPEX- benzocaine gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated February 4, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 Razzberry

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

    Liquid – 1oz/30mL
    REF AD31011 Cherry
    REF AD31012 Mint
    REF AD31014 Pina Colada USP – 2oz/57g

    NPN Number: 00638358
    For dental use only.
    USA: Rx only.

  • 1. DESCRIPTION

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

  • 2. INDICATIONS

    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.

  • 3. CONTRAINDICATIONS

    Should not be used with individuals with a known sensitivity to benzocaine or PABA.

  • 4. WARNINGS

    Keep out of reach of children. For professional dental use only.

  • 5. PRECAUTIONS

    Topex 20% benzocaine gels and liquids are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

  • 6. DOSAGE AND ADMINISTRATION

    1. Each gram of Topex 20% benzocaine gel or liquid contains between 180-220mg benzocaine in a flavored base.
    2. 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.
    3. 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.
    4. Tightly re-cap the jar after each use.
  • 7. STORAGE

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

  • SPL UNCLASSIFIED SECTION

    SultanHealthcare
    411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601
    Toll Free: 800-637-8582 • Phone: 201-871-1232
    Fax: 201-871-0321 • www.sultanhealthcare.com

    Made in the USA
    Form #0030502DF (R 7/22/09)

  • PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

    NPN 00638358

    TOPEX®
    TOPICAL
    ANESTHETIC
    GEL

    (Benzocaine 20%)

    CHERRY

    Net Content 100g

    PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
  • PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

    NPN 00638358

    TOPEX®
    TOPICAL
    ANESTHETIC
    GEL

    (Benzocaine 20%)

    MINT

    Net Content 100g

    PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
  • PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

    NPN 00638358

    TOPEX®
    TOPICAL
    ANESTHETIC
    GEL

    (Benzocaine 20%)

    PIÑA COLADA

    Net Content 100g

    PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
  • PRINCIPAL DISPLAY PANEL - 100 gram Jar Label

    NPN 00638358

    TOPEX®
    TOPICAL
    ANESTHETIC
    GEL

    (Benzocaine 20%)

    BUBBLE NUM®

    Net Content 100g

    PRINCIPAL DISPLAY PANEL - 100 gram Jar Label
  • INGREDIENTS AND APPEARANCE
    TOPEX 
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10216-3071
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10216-3071-1100 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX 
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10216-3081
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10216-3081-1100 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX 
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10216-3091
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10216-3091-1100 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX 
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10216-3110
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10216-3110-1100 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    Labeler - DENTSPLY Caulk (083235549)
    Establishment
    NameAddressID/FEIBusiness Operations
    DENTSPLY Caulk083235549MANUFACTURE