Label: BENZO-JEL- benzocaine gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 27, 2010

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  • INGREDIENTS

    Each gram of Benzo-Jel™ 20% benzocaine gel contains between 180-220 mg benzocaine USP, in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.

  • USUAL DOSAGE

    For oral mucosal use only as directed by a dentist.

  • WARNING

    Keep out of the reach of children.

  • STORAGE AND HANDLING

    Store at controlled room temperature 59°-86°F (15°-30°C).

  • SPL UNCLASSIFIED SECTION

    Do not use on people with known allergies to benzocaine and PABA compounds.

  • CAUTION

    Federal law (USA) prohibits dispensing without prescription.

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    HENRY SCHEIN INC.
    Melville, NY 11747

  • PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

    HENRY SCHEIN®

    BENZO-JEL™
    TOPICAL ANESTHETIC GEL

    Raspberry Flavor

    20% Benzocaine
    FOR PROFESSIONAL USE ONLY
    1 FL. OZ. (29.6 mL)

    PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BENZO-JEL   RASPBERRY
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-3416
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-3416-0134 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/19/1963
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - DSHealthcare (056296981)
    Establishment
    NameAddressID/FEIBusiness Operations
    DENTSPLY Caulk083235549MANUFACTURE
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