Label: TOPICAL ANESTHETIC- benzocaine gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 13, 2010

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  • INGREDIENTS

    Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and FD&C Red #40.

  • USUAL DOSAGE

    For oral mucosal use only as directed by a dentist.

  • CAUTION

    Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic response. Federal law prohibits dispensing without a prescription.

  • WARNING

    Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.

  • HOW SUPPLIED

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

  • SPL UNCLASSIFIED SECTION

    MADE IN U.S.A.

    Distributed by:

    PATTERSON
    DENTAL
    Corporate Office
    1031 Mendota Heights Road
    Saint Paul, MN 55120

    PATTERSON
    DENTAL /
    Montréal Québec
    H3M 3E6

  • PRINCIPAL DISPLAY PANEL - 29.6 mL Label

    PATTERSON
    DENTAL

    Topical Anesthetic

    Banana Flavor Gel
    Contains 20% Benzocaine

    For Professional Use Only
    Net Contents 1 fl oz (29.6 mL)

    Reorder Number
    089-9989

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TOPICAL ANESTHETIC   BANANA
    benzocaine gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50227-2116
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBANANAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50227-2116-134 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/19/1963
    Labeler - Patterson Dental (171843584)
    Registrant - DSHealthcare (056296981)
    Establishment
    NameAddressID/FEIBusiness Operations
    DENTSPLY Caulk083235549MANUFACTURE
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