Label: TOPICAL ANESTHETIC MINT- benzocaine gel

  • Category: HUMAN OTC 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 April 6, 2012

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  • ACTIVE INGREDIENT

    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 Green #5.

  • USUAL DOSAGE

    For oral mucosal use only as directed by a dentist.

  • INDICATIONS & USAGE

    CAUTION

    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
    Patterson Dental Supply, Inc.
    1031 Mendota Heights Road
    Saint Paul, MN 55120

  • PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

    PATTERSON
    DENTAL

    NDC#50227-2112-1

    Topical Anesthetic

    Mint Flavor Gel

    Contains 20% Benzocaine

    For Professional Use Only

    Net Contents 1 fl oz (29.6 mL)

    Reorder Number
    090-0001

    PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
  • INGREDIENTS AND APPEARANCE
    TOPICAL ANESTHETIC   MINT
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50227-2112
    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 Dihydrate (UNII: SB8ZUX40TY)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50227-2112-129.6 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 Supply Inc (171843584)
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