Label: BENZ O STHETIC- 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 August 10, 2016

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  • Drugs Facts


    Active Ingredients Purpose
    Benzocaine 20% Anesthetic

  • Uses

    For temporary relief of oral pain associated with: · toothache ·canker sores ·minor dental
    procedures · minor injury of the mouth and gum caused by dentures or orthodontic appliances.

  • Directions

    Apply with cotton applicator or finger tip to affected gum area
    up to 4 times a day or as directed by your dentist.

  • DOSAGE & ADMINISTRATION

    Do not use for more thatn 7 days.

  • Warnings

    Do not use this product if you have a history of allergy to
    local anesthetic such as Procaine, Benzocaine or other
    “Caines”. Not recommended for children under the age of 2.

  • Other Ingredients

    Benzyl Alcohol, Cherry Flavor, FD&C Red #40, PEG 3350, PEG 400, Sodium Saccharin

  • Storage

    Store at controlled room temperature 20-25°C (68-77°F).

  • Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL



    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    BENZ O STHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-926
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-926-1515 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    2NDC:54162-926-2929 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-926)
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