Label: TOPEX- benzocaine spray, metered

  • NDC Code(s): 0699-3100-02
  • 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 20, 2017

If you are a consumer or patient please visit this version.

  • INDICATIONS AND USAGE

    Topical anesthetic for use on oral mucosa

  • DOSAGE AND ADMINISTRATION

    Attach disposable straw to the spray valve. Spray directly on mucosa to achieve topical anesthesia.

  • DOSAGE FORMS AND STRENGTHS

    Each gram of Topex 20% benzocaine topical anesthetic spray contains between 180-220 mg benzocaine. Each metered spray delivers approximately 6.8 mg of benzocaine.

  • CONTRAINDICATIONS

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

  • 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.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL - Carton

    Cherry carton

  • INGREDIENTS AND APPEARANCE
    TOPEX 
    benzocaine spray, metered
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0699-3100
    Route of AdministrationPERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE220 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    APAFLURANE (UNII: R40P36GDK6)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0699-3100-021 in 1 CARTON01/01/1900
    157 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/1900
    Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sciarra Laboratories, Inc.824900369manufacture(0699-3100)