Label: 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

  • NDC Code(s): 0699-7001-34, 0699-7011-34, 0699-7021-34, 0699-7031-34, view more
    0699-7051-34, 0699-7061-34, 0699-7071-01, 0699-7081-01, 0699-7091-01, 0699-7100-01
  • Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 12, 2023

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  • 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

    Cherry 1 oz

  • PRINCIPAL DISPLAY PANEL - Mint 34 gram

    Mint 1 oz

  • PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram

    P Colada 1 oz

  • PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram

    B Num 1 oz

  • PRINCIPAL DISPLAY PANEL - Strawberry 34 gram

    Strawberry 1 oz

  • PRINCIPAL DISPLAY PANEL - Razzberry 34 gram

    Razzberry 1 oz

  • PRINCIPAL DISPLAY PANEL - Cherry 100 gram

    Cherry 100 gram

  • PRINCIPAL DISPLAY PANEL - Mint 100 gram

    Mint 100 g

  • PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram

    P Colada 100 g

  • PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram

    B Num 100 g

  • INGREDIENTS AND APPEARANCE
    TOPEX   PINA COLADA
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7001-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/196304/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/196304/14/2023
    TOPEX   CHERRY
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7021
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7021-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   MINT
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7011
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7011-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   BUBBLE GUM
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7031
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7031-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   STRAWBERRY
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7051
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorREDScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7051-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   RASPBERRY
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7061
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorREDScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7061-3434 g in 1 JAR; Type 0: Not a Combination Product02/19/196309/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/196309/11/2022
    TOPEX   CHERRY
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7071
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7071-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   MINT
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7081
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7081-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    TOPEX   PINA COLADA
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7091
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCOCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7091-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/196302/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/196302/28/2019
    TOPEX   BUBBLE GUM
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-7100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-7100-01100 g in 1 JAR; Type 0: Not a Combination Product02/19/196301/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/196301/18/2022
    Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dentsply Caulk083235549MANUFACTURE(0699-7001, 0699-7011, 0699-7021, 0699-7031, 0699-7051, 0699-7061, 0699-7071, 0699-7081, 0699-7091, 0699-7100)
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