Label: BENZO JEL- benzocaine spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

    • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
    • For Professional Use Only.
  • Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a setious condition that must be treated promptiy because it reduces the amount of oxygen canied in the blood. This can occur even if you have used this product before. Slop use and seek immediate medical attention tt you or a child in your care develops:

    • pale, gray or blue colored skn (cyanosis)
    • headache
    • rapid heart rate
    • shortress of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Flammable. Do not use near fire or flame. Avoid smoking during use.

    Do not use:

    • for teething
    • in children under 2 years of age

  • ​Keep out of reach of children.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center nght away. Avoid spraying in eyes.

  • Dosage

    ​A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

  • Other information

    Store at room temperature.  Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

  • Inactive ingredients

    Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).

  • ​Questions or comments?

    1-800-472-4346

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    BENZO JEL 
    benzocaine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0018
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0018-3557 g in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/01/2016
    Labeler - Henry Schein Inc. (012430880)