Label: GINGICAINE GEL, MINT JULEP- gingicaine gel, mint julep flabvor gel

  • NDC Code(s): 10129-063-03, 10129-063-05
  • Packager: Gingi-Pak a Division of the Belport
  • 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 December 8, 2021

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  • Active Ingredient

    Active Ingredient

  • Inactive Ingredient

    Inactive Ingredient

  • Precautions

    Precautions

  • Consult a doctor promptly

    Consult a doctor promptly

  • Allergy Alert and Contraindications

    Allergy AlertContraindications

  • Purpose

    Purpose

  • Keep out of reach of children

    Keep out of reach of children

  • Dosage and Administration

    Dosage and Administration001Dosage and Administration002

  • Indications and Uses

    IndicationsUses

  • Avoid excessive heat

    Avoid excessive heat

  • Warnings

    Warnings

  • Mint Julep Label

    Jar label

  • INGREDIENTS AND APPEARANCE
    GINGICAINE GEL, MINT JULEP 
    gingicaine gel, mint julep flabvor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10129-063
    Route of AdministrationDENTAL, ORAL, PERIODONTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 260 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 520 mg
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) 20 mg
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Mint Julep) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10129-063-031 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/1998
    2NDC:10129-063-056 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/13/1998
    Labeler - Gingi-Pak a Division of the Belport (008480121)
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